Glossary
MedTech Glossary
Every term in the dictionary, listed alphabetically. Search by term, acronym, or category, then jump to a full definition.
513 of 513 terms
54 terms
- 5-Day ReportPost-MarketExpedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm.
- 510(k) Premarket Notification(510(k))RegulatoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
- 510(k) Summary vs 510(k) StatementRegulatoryTwo alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
- 513(g) Request for Information(513(g))RegulatoryFormal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
A37 terms
- AAMI(AAMI)Industry BodiesStandards body for medical instrumentation; co-publisher of ISO/IEC adoptions.
- AAMI SW96CybersecurityAAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle.
- AAMI TIR45(TIR45)Software & AIAAMI Technical Information Report providing guidance on applying Agile software development practices within an IEC 62304-compliant medical device software lifecycle.
- AAMI TIR57CybersecurityAAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management.
- AAMI TIR97(TIR97)CybersecurityAAMI Technical Information Report on post-market security risk management for medical device manufacturers, the operational companion to TIR57.
- Abbreviated 510(k)Regulatory510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
- Accreditation Scheme for Conformity Assessment(ASCA)RegulatoryFDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.
- Adaptive Trial DesignClinical & TrialsTrial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
- Additional Condition for Nonprescription Use(ACNU)RegulatoryFDA's 2024 final rule creating a pathway for nonprescription drug products that rely on additional conditions (e.g., self-selection tools, drug-device combinations) to ensure safe use without a healthcare provider.
- AdvaMedIndustry BodiesU.S. trade association for the medical device and diagnostics industry.
- AdvaMed Code of EthicsCommercializationIndustry code governing interactions between U.S. medical-device companies and healthcare professionals.
- AdvaMedDxIndustry BodiesDiagnostics-focused division of AdvaMed.
- Adversarial RobustnessSoftware & AIResilience of an ML model to inputs deliberately crafted to cause misclassification.
- Adverse Event(AE)Clinical & TrialsAny untoward medical occurrence in a subject, whether or not related to the device.
- Advisory BoardCommercializationConvening of external experts to advise on strategy or product.
- Aesthetic & Energy-Based DevicesMarket SegmentsLasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions.
- AI Act Conformity Assessment (Medical Devices)RegulatoryFor AI-enabled medical devices, AI Act requirements are assessed through the MDR/IVDR notified-body procedure, not a separate CE route.
- AI Act Post-Market MonitoringRegulatoryOngoing, documented monitoring of a high-risk AI system's performance after it is placed on the market.
- AI Act Prohibited PracticesRegulatoryArticle 5 practices banned outright in the EU, including subliminal manipulation and untargeted facial-recognition scraping.
- AI Act Serious Incident ReportingRegulatoryDuty on providers of high-risk AI systems to report serious incidents to national market-surveillance authorities.
- AI Act Technical Documentation (Annex IV)RegulatoryThe information set a provider must maintain to demonstrate a high-risk AI system's compliance with Articles 8 to 15.
- AI Act Transparency ObligationsRegulatoryArticle 50 requirements for specific AI systems, including disclosure that a user is interacting with AI and labelling of synthetic content.
- AI Imaging SoftwareMarket SegmentsSoftware that analyzes medical images to triage, detect, or quantify disease.
- AI/ML-Enabled Medical DeviceSoftware & AIMedical device that uses artificial intelligence or machine learning to perform its intended use.
- ALCOA+Clinical & TrialsData integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available).
- Algorithm Change Protocol(ACP)Software & AIThe detailed procedural section of a PCCP that specifies how planned modifications to an AI/ML model will be developed, validated, and implemented.
- Algorithmic Bias and FairnessSoftware & AISystematic differences in model performance across demographic or clinical subgroups.
- Ambulatory Payment Classification(APC)ReimbursementThe Medicare grouping system that determines hospital outpatient payment amounts under OPPS, analogous to MS-DRGs for inpatient.
- Analytical Performance (IVDR)RegulatoryThe ability of an IVD to correctly detect or measure a particular analyte.
- Analytical SensitivityClinical & TrialsAn IVD's ability to detect small quantities of an analyte.
- Annual Report (PMA)Post-MarketYearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status.
- Anti-Dilution ProtectionInvestment & FinanceAdjustment that protects investors if the company raises a future round at a lower price.
- Anti-Kickback Statute(AKS)CommercializationU.S. criminal statute prohibiting remuneration to induce federal healthcare business.
- ANVISA(ANVISA)RegulatoryBrazil's National Health Surveillance Agency, regulating medical devices and IVDs.
- ASC Site-of-Service ShiftReimbursementMigration of procedures from hospitals to ambulatory surgery centers.
- ASTM F2503StandardsStandard practice for marking medical devices and other items for safety in the magnetic resonance environment.
- Authorized Representative (EU)(EC REP)RegulatoryLegal entity established in the EU that represents a non-EU manufacturer for MDR/IVDR purposes.
B15 terms
- Bayesian Trial DesignClinical & TrialsTrial design that uses Bayesian statistics, often incorporating prior data from related studies or registries.
- Benefit-Risk DeterminationRegulatoryAssessment weighing probable benefits against probable risks of a device.
- Bill of Materials(BOM)ManufacturingStructured list of every component, sub-assembly, and quantity needed to manufacture a device.
- BioburdenManufacturingQuantification of viable microorganisms on or in a product before sterilization.
- BiocompatibilityQuality & RiskAbility of a material to perform with an appropriate host response in a specific application.
- Blinding and MaskingClinical & TrialsProcedures that hide treatment assignment from patients, investigators, or assessors to reduce bias.
- Board of DirectorsInvestment & FinanceThe governing body elected by stockholders that oversees management, approves major corporate actions, and typically includes investor-designated seats after venture financing.
- Bottom-Up Market SizingCommercializationBuilding market size from procedure volumes × price × penetration.
- BrainjackingCybersecurityUnauthorized remote control of an implanted neurostimulator (e.g., DBS) to alter stimulation parameters and harm a patient.
- Breakthrough Device Designation(BDD)RegulatoryFDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.
- Bridge RoundInvestment & FinanceInterim financing between priced rounds, usually convertible.
- Budget Impact Model(BIM)ReimbursementFinancial model that estimates the total cost consequences of adopting a new technology to a payer's budget over a defined horizon.
- Bundled PaymentReimbursementSingle payment that covers all services for an episode of care.
- Burn RateInvestment & FinanceRate at which a company spends cash, typically expressed monthly.
- Burn Rate and RunwayInvestment & FinanceMonthly net cash consumption (burn) and months of cash remaining (runway).
C48 terms
- CAPA Effectiveness CheckQuality & RiskVerification step confirming a corrective or preventive action actually fixed the problem.
- Capitalization Table(Cap Table)Investment & FinanceLedger of all securities issued by a company and who owns them.
- Cardiac Rhythm Management(CRM)Market SegmentsImplantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors.
- Cardiovascular DevicesMarket SegmentsDevices for diagnosing, monitoring, or treating cardiovascular disease.
- Case Report Form(CRF)Clinical & TrialsStructured paper or electronic forms used to capture protocol-required data for each enrolled subject.
- Category III CPT CodeReimbursementTemporary CPT code for emerging technologies and services.
- Category III CPT CodesReimbursementTemporary CPT codes for emerging technologies, services, and procedures.
- CE MarkRegulatoryMandatory European conformity mark for medical devices placed on the EU market.
- Change ControlQuality & RiskFormal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance.
- CISA Known Exploited Vulnerabilities Catalog(KEV)CybersecurityCISA's authoritative list of CVEs with confirmed in-the-wild exploitation, with mandatory federal remediation deadlines.
- Class D Batch Verification (IVDR)RegulatoryPre-release testing of every manufactured batch of Class D IVDs by an EU Reference Laboratory, where designated.
- Class III DeviceRegulatoryFDA's highest-risk device class, generally requiring PMA.
- Cleanroom Classes (ISO 14644)ManufacturingISO 14644 classification of cleanrooms by airborne particulate cleanliness (ISO 1 through ISO 9).
- Clinical and Laboratory Standards Institute(CLSI)Industry BodiesUS-based consensus standards organization whose documents establish widely used analytical and clinical laboratory performance evaluation protocols for IVDs.
- Clinical Decision Support(CDS)Software & AISoftware providing healthcare professionals with knowledge and patient-specific information.
- Clinical Evaluation Consultation Procedure(CECP)RegulatoryMDR Article 54 procedure in which an independent expert panel reviews the notified body's clinical evaluation assessment for certain Class III and implantable Class IIb devices.
- Clinical Evaluation Plan(CEP)Clinical & TrialsEU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER).
- Clinical Evaluation Report(CER)Clinical & TrialsDocumented assessment of clinical data demonstrating EU MDR conformity for a device.
- Clinical Investigation Plan(CIP)Clinical & TrialsEU MDR's term for the protocol document governing a clinical investigation of a device.
- Clinical Laboratory Improvement Amendments(CLIA)Market SegmentsU.S. federal standards that govern clinical laboratory testing.
- Clinical Performance (IVDR)RegulatoryThe ability of an IVD to yield results correlated with a clinical condition in the target population and intended user.
- CMS IDE Coverage (Category A & B)ReimbursementMedicare coverage framework for items and services furnished in FDA-approved IDE studies, Category A (experimental) and Category B (non-experimental).
- Code SigningCybersecurityCryptographic signing of executable software and firmware so that only authentic, unmodified code from a trusted publisher will run.
- Combination ProductRegulatoryProduct comprised of two or more regulated components - e.g., drug-device, biologic-device.
- Common Specifications(CS)RegulatoryMandatory technical specifications under EU MDR/IVDR where harmonized standards are insufficient.
- Common Specifications (IVDR)(CS)RegulatoryTechnical or clinical requirements adopted by Commission implementing act that manufacturers must comply with unless a demonstrably equivalent alternative is used.
- Common StockInvestment & FinanceThe base class of equity typically held by founders and employees, standing last in the distribution waterfall behind creditors and preferred stockholders.
- Common Vulnerabilities and Exposures(CVE)CybersecurityA globally unique identifier for a publicly disclosed cybersecurity vulnerability.
- Common Vulnerability Scoring System(CVSS)CybersecurityAn industry-standard 0–10 score that quantifies the severity of a software vulnerability.
- Common Weakness Enumeration(CWE)CybersecurityCommunity-maintained list of software and hardware weakness types, the underlying defects that cause CVEs.
- Companion Diagnostic(CDx)Market SegmentsIVD that identifies patients who will benefit from a specific drug.
- Companion Diagnostic (IVDR)(CDx)RegulatoryIVD that is essential for the safe and effective use of a corresponding medicinal product to identify eligible patients or monitor treatment response.
- Complaint HandlingQuality & RiskProcess for receiving, evaluating, and responding to device complaints.
- Composite EndpointClinical & TrialsSingle endpoint combining multiple component outcomes (e.g., MACE = death + MI + stroke).
- Container Closure Integrity(CCI)ManufacturingDemonstration that a sterile package maintains microbial barrier and contents integrity over the labeled shelf life.
- Contract Research Organization(CRO)Industry BodiesService organization providing clinical trial management and supporting services to sponsors.
- Convertible NoteInvestment & FinanceShort-term debt that converts into equity at a future financing round.
- Coordinated Vulnerability Disclosure(CVD)CybersecurityA documented process for receiving, triaging, and responsibly disclosing security vulnerabilities reported by external researchers.
- Core LaboratoryClinical & TrialsAn independent, centralized laboratory that performs standardized, blinded analysis of imaging or physiologic data from multiple trial sites to produce consistent endpoint adjudication.
- Corporate Venture Capital(CVC)Industry BodiesVenture arms of strategic MedTech and pharma companies investing in adjacent or complementary innovation.
- Corrective and Preventive Action(CAPA)Quality & RiskSystematic process to investigate and resolve quality issues and prevent recurrence.
- Counterfeit Parts and Suspect ComponentsManufacturingRisk of unauthorized, fraudulent, or substandard components entering the supply chain.
- Coverage with Evidence Development(CED)ReimbursementMedicare paradigm conditioning coverage on participation in approved clinical studies or registries.
- CPT Codes(CPT)ReimbursementAMA-maintained codes that describe medical procedures and services.
- Cryptographic AgilityCybersecurityThe designed-in ability to replace cryptographic primitives over a device's supported lifetime.
- Current Procedural Terminology Codes(CPT)ReimbursementAMA-maintained codes used to report medical procedures and services for billing.
- Customer Notification LetterPost-MarketCommunication to users notifying them of a safety issue, corrective action, or important product information.
- CycloneDXCybersecurityA lightweight, OWASP-maintained SBOM format designed for application security and supply-chain use cases.
D26 terms
- Data Governance (AI/ML)Software & AIPolicies, controls, and documentation for the data used to train, tune, and validate medical AI models.
- Data Safety Monitoring Board(DSMB)Clinical & TrialsIndependent committee that periodically reviews accumulating safety and (sometimes) efficacy data during a trial.
- Datasheets for DatasetsSoftware & AIStructured documentation describing a dataset's motivation, composition, collection process, preprocessing, uses, and maintenance, the dataset equivalent of a model card.
- De Novo Classification Request(De Novo)RegulatoryPathway to classify novel low- to moderate-risk devices that lack a predicate.
- De-Identification of Health DataCybersecurityThe HIPAA-defined process of removing identifiers from PHI so the resulting data is no longer subject to the Privacy Rule.
- Decentralized Clinical Trial(DCT)Clinical & TrialsA trial that uses telehealth, home-based assessments, wearables, and direct-to-patient logistics to reduce or eliminate site visits.
- Dental DevicesMarket SegmentsDevices used in dentistry, implants, CAD/CAM restorations, clear aligners, intraoral scanners, and dental radiography.
- Design ControlsQuality & RiskStructured process governing the design of medical devices.
- Design History File(DHF)Quality & RiskCompilation of records describing the design history of a finished device.
- Design TransferManufacturingTranslating design into production specifications.
- Device History Record(DHR)ManufacturingRecords demonstrating that a device is manufactured per the DMR.
- Device Master File(MAF)RegulatoryConfidential FDA submission allowing a supplier to share proprietary information with multiple device manufacturers' submissions without disclosing it to them.
- Device Master Record(DMR)ManufacturingCompilation of records containing the procedures and specifications for a finished device.
- Device Reclassification PetitionRegulatoryFormal request to FDA to move a device type from one classification (I, II, or III) to another, either down-classifying or up-classifying.
- Diabetes CareMarket SegmentsDevices for glucose monitoring and insulin delivery.
- Digital Therapeutic(DTx)Market SegmentsSoftware-based intervention that delivers evidence-based therapy to prevent, manage, or treat a disease.
- Digital Therapeutics(DTx)Market SegmentsSoftware-based interventions that prevent, manage, or treat disease.
- DilutionInvestment & FinanceReduction in existing shareholder ownership when new shares are issued.
- Distribution WaterfallInvestment & FinanceThe order in which sale or liquidation proceeds are paid out to creditors, preferred stockholders, and common stockholders based on liquidation preferences and conversion decisions.
- Distributor vs Direct SalesCommercializationChoice between selling through third-party distributors or hiring a direct salesforce.
- Document ControlQuality & RiskProcedures ensuring approved, current documents are used and obsolete copies removed.
- Down RoundInvestment & FinanceFinancing at a lower per-share price than the previous round.
- Drag-Along and Tag-Along RightsInvestment & FinanceStockholder agreement provisions that compel minority holders to join a sale (drag) or entitle them to participate pro rata in a major holder's sale (tag).
- Drug Delivery DevicesMarket SegmentsDevices that administer therapeutics - autoinjectors, pumps, inhalers.
- Due DiligenceInvestment & FinanceInvestigation of a company before an investment, financing, or acquisition.
- Durable Medical Equipment, Prosthetics, Orthotics, and Supplies(DMEPOS)ReimbursementMedicare benefit category covering durable medical equipment, prosthetics, orthotics, and supplies, billed under HCPCS Level II codes through DME MACs.
E22 terms
- Early Feasibility Study(EFS)Clinical & TrialsFDA program enabling early human evaluation of novel devices with limited preclinical data and iterative design.
- Earn-OutInvestment & FinanceAcquisition consideration paid contingently after closing based on achievement of agreed milestones (regulatory, revenue, or technical).
- Electronic Data Capture(EDC)Clinical & TrialsSoftware systems used to collect, manage, and report clinical trial data electronically, replacing paper case report forms.
- Electronic Instructions for Use(eIFU)RegulatoryProvision of IFU in electronic form instead of, or in addition to, paper.
- Electronic Medical Device Reporting(eMDR)Post-MarketFDA's mandatory electronic submission system for Medical Device Reports.
- Electronic Patient-Reported Outcome(ePRO)Clinical & TrialsA patient-reported outcome instrument administered and captured electronically, subject to validation and 21 CFR Part 11 data-integrity requirements when used in FDA-regulated trials.
- Electrophysiology(EP)Market SegmentsDiagnosis and catheter-based treatment of cardiac arrhythmias.
- Emergency Use Authorization(EUA)RegulatoryFDA authority to permit the use of unapproved medical products, or unapproved uses of approved products, during declared public health emergencies.
- Employee Option PoolInvestment & FinanceShares reserved for issuance to employees as stock options.
- Endoscopy DevicesMarket SegmentsFlexible and rigid scopes plus accessories used for visualization, diagnosis, and therapy inside the GI tract, airways, urinary tract, and joints.
- Endotoxin Testing (LAL)ManufacturingDetection of bacterial endotoxin on devices, typically using Limulus Amebocyte Lysate (LAL) assays.
- Engineering Change Order / Notice(ECO / ECN)ManufacturingDocuments that authorize and communicate changes to released designs, BOMs, or manufacturing processes.
- ENT DevicesMarket SegmentsDevices for ear, nose, and throat conditions.
- Essential PerformanceStandardsPerformance of a clinical function whose loss or degradation would result in unacceptable risk.
- eSTARRegulatoryFDA's interactive PDF template for preparing and submitting 510(k) and De Novo submissions.
- EU AI ActSoftware & AIEU regulation establishing risk-based requirements for AI systems, including most medical AI.
- EU In Vitro Diagnostic Regulation(IVDR)RegulatoryRegulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
- EU Medical Device Regulation(MDR)RegulatoryRegulation (EU) 2017/745 governing medical devices in the European Union.
- EU Reference Laboratory (EURL)(EURL)RegulatoryLaboratory designated by the Commission to verify performance of Class D IVDs and provide scientific advice.
- EUDAMEDRegulatoryEuropean Database on Medical Devices.
- Exit MultipleInvestment & FinanceValuation ratio applied at exit, e.g., enterprise value to revenue.
- Explainability and InterpretabilitySoftware & AIMethods (SHAP, saliency maps, prototype explanations) that help users understand why a model made a given prediction.
F17 terms
- Failure Mode and Effects Analysis(FMEA)Quality & RiskBottom-up technique for systematically identifying potential failures and their effects.
- Fault Tree Analysis(FTA)Quality & RiskTop-down deductive analysis tracing how faults can combine to cause an undesired event.
- FDA Form 483Quality & RiskNotice of inspectional observations issued at the conclusion of an FDA inspection.
- FDA Recall Classifications I, II, IIIPost-MarketFDA's risk-based grading of recalls based on potential for harm.
- FDA Recognized Consensus StandardsRegulatoryVoluntary standards that FDA has formally recognized for use in establishing device conformity.
- Feasibility StudyClinical & TrialsSmall clinical study evaluating initial safety, usability, and design parameters of an investigational device.
- Federated LearningSoftware & AITraining paradigm where model updates are computed on local data and aggregated centrally - raw data never leaves the site.
- FedRAMP(FedRAMP)CybersecurityU.S. government-wide program that standardizes security assessment, authorization, and continuous monitoring for cloud services sold to federal agencies.
- Field Action vs RecallPost-MarketDistinction between corrective field actions taken on devices in the field and FDA-defined recall events.
- Field Clinical Engineer(FCE)CommercializationManufacturer representative providing clinical and technical support in the OR or cath lab.
- Field Safety Corrective Action(FSCA)Post-MarketAction taken to reduce a risk of serious deterioration in health associated with a device.
- First-in-Human Study(FIH)Clinical & TrialsFirst clinical use of a device or therapy in humans, often outside the U.S. before a U.S. EFS.
- Fogarty InnovationIndustry BodiesNon-profit MedTech incubator carrying on the legacy of Dr. Thomas Fogarty.
- Foundation Model (Healthcare)Software & AILarge pretrained model adaptable to many downstream clinical tasks via fine-tuning or prompting.
- Freedom to Operate(FTO)CommercializationAnalysis of whether a product can be sold without infringing third-party IP.
- Fully Diluted SharesInvestment & FinanceThe total share count assuming exercise or conversion of all outstanding options, warrants, convertible securities, and reserved but unissued option pool shares.
- Fundamental Rights Impact Assessment(FRIA)RegulatoryAssessment deployers of certain high-risk AI systems must complete before first use.
G10 terms
- General ControlsRegulatoryBaseline FDA requirements that apply to all medical devices regardless of class.
- General Safety and Performance Requirements(GSPRs)RegulatoryAnnex I requirements under EU MDR/IVDR that every device must demonstrate it meets.
- General Safety and Performance Requirements (IVDR)(GSPR)RegulatoryAnnex I of the IVDR: the mandatory safety, performance, and information requirements every IVD must meet regardless of class.
- General-Purpose AI Model(GPAI)RegulatoryAI model trained on broad data at scale that displays significant generality and can be integrated into many downstream systems.
- Generative AI in Medical DevicesSoftware & AIDevices that use LLMs or diffusion models to generate text, images, or recommendations within a clinical workflow.
- Genetic Testing Requirements (IVDR Article 4)RegulatoryMember-State-level obligations on information, counselling, and consent for genetic testing performed with IVDs.
- Global Unique Device Identification Database(GUDID)Post-MarketFDA database holding key device identification information for all UDIs.
- Good Clinical Practice(GCP)CommercializationInternational quality standard for designing and conducting clinical trials.
- Good Machine Learning Practice(GMLP)Software & AIGuiding principles for the development of AI/ML-enabled medical devices.
- Group Purchasing Organization(GPO)CommercializationEntity that aggregates hospital purchasing to negotiate prices with suppliers.
H21 terms
- Hardcoded CredentialsCybersecuritySecrets - passwords, API keys, certificates - embedded in firmware or source code shipped on every device.
- Hardware Root of Trust(HRoT)CybersecurityA tamper-resistant hardware element (TPM, secure element, or fused boot ROM) that provides the foundational, unforgeable trust anchor for secure boot, attestation, and key storage.
- Harmonised StandardsStandardsEuropean standards cited by reference in the Official Journal of the EU that give manufacturers a presumption of conformity with corresponding legal requirements.
- Hazard AnalysisQuality & RiskThe systematic identification of hazards, foreseeable sequences of events, and resulting hazardous situations that underpins a device's ISO 14971 risk management process.
- Hazard, Hazardous Situation, and HarmQuality & RiskISO 14971 distinction underpinning all medical-device risk analysis.
- HCPCS Codes(HCPCS)ReimbursementCMS-maintained codes for products, supplies, and services not in CPT.
- Health Canada Medical Device Licence(MDL)RegulatoryAuthorization required to import or sell Class II, III, or IV medical devices in Canada.
- Health Economics and Outcomes Research(HEOR)ReimbursementResearch discipline that generates economic, clinical, and patient-reported evidence to support payer access, HTA submissions, and value demonstration.
- Health Hazard Evaluation(HHE)Post-MarketStructured assessment of patient/user risk used to support recall classification and field-action decisions.
- Health Industry Cybersecurity Practices(HICP)CybersecurityConsensus cybersecurity practices for healthcare published under HHS Section 405(d), the recognized 'reasonable practices' safe-harbor reference.
- Health Information Sharing and Analysis Center(H-ISAC)CybersecurityMember-driven nonprofit that operates the trusted sharing community for cyber and physical threat intelligence across the healthcare sector.
- Health Technology Assessment(HTA)ReimbursementSystematic evaluation of clinical and economic value of a health technology.
- Healthcare and Public Health Cybersecurity Performance Goals(HPH-CPG)CybersecurityHHS's sector-specific list of essential and enhanced cybersecurity goals for healthcare, derived from HICP and the NIST CSF.
- Hearing DevicesMarket SegmentsAir-conduction and bone-conduction hearing aids, OTC hearing aids, and cochlear implants, spanning Class I, II, and III pathways.
- High-Risk AI System (EU AI Act)RegulatoryAI systems captured by Article 6 of the EU AI Act because they are safety components of regulated products or listed in Annex III.
- HIPAA(HIPAA)CybersecurityU.S. federal law governing the privacy and security of protected health information.
- HITECH Act(HITECH)CybersecurityU.S. law that strengthened HIPAA enforcement and introduced breach-notification requirements.
- HITRUST CSF(HITRUST)CybersecurityHealthcare-focused certifiable security framework that consolidates HIPAA, NIST, ISO 27001, and other authorities into a unified control set.
- HSCC Joint Security Plan(HSCC JSP)CybersecurityAn industry-developed reference framework from the Healthcare Sector Coordinating Council for end-to-end MedTech cybersecurity.
- Human Factors Engineering(HFE)Clinical & TrialsEngineering discipline focused on safe and effective device use by intended users.
- Humanitarian Device Exemption(HDE)RegulatoryFDA marketing pathway for devices treating rare conditions affecting fewer than 8,000 U.S. patients per year.
I60 terms
- ICD-10-CM / ICD-10-PCSReimbursementDiagnosis (CM) and inpatient procedure (PCS) coding systems used in U.S. claims.
- ICH E6 Good Clinical Practice(GCP)Clinical & TrialsInternational standard for the design, conduct, and reporting of clinical trials.
- ICH E6(R3) Good Clinical Practice(E6(R3))StandardsRevision 3 of the ICH Good Clinical Practice guideline, restructured around principles, modernized for risk-based and decentralized trials, finalized in 2023.
- ICS Medical Advisory(ICSMA)CybersecurityCISA's official vulnerability advisories for medical devices, the public record of disclosed device cybersecurity issues, indexed as ICSMA-YY-DDD-NN.
- IDE Annual Progress ReportClinical & TrialsAnnual report sponsors must submit to FDA summarizing the progress of an approved IDE study, including enrollment, deviations, and adverse events.
- IDE SupplementClinical & TrialsAmendment to an approved Investigational Device Exemption for protocol or device changes.
- IEC 60601-1StandardsGeneral requirements for basic safety and essential performance of medical electrical equipment.
- IEC 60601-1-2StandardsEMC requirements for medical electrical equipment.
- IEC 60825StandardsStandard for safety of laser products, including laser-based medical devices.
- IEC 62304StandardsLifecycle requirements for medical device software.
- IEC 62366-1StandardsApplication of usability engineering to medical devices.
- IEC 80001-1CybersecurityInternational standard for risk management of IT networks that incorporate medical devices.
- IEC 81001-5-1CybersecurityInternational standard defining secure-product-lifecycle activities for health software, including medical devices.
- IEC 82304-1StandardsStandard for health software products - covering general requirements for product safety.
- IMDRFRegulatoryInternational Medical Device Regulators Forum.
- IMDRF Principles and Practices for Medical Device CybersecurityCybersecurityInternational harmonized guidance on medical-device cybersecurity from the IMDRF Cybersecurity Working Group.
- Importer and Distributor Obligations (EU)RegulatoryMDR/IVDR places verification, labeling, traceability, and vigilance duties on importers and distributors.
- In Vitro Diagnostics(IVD)Market SegmentsTests performed on biological samples outside the body.
- In Vitro Diagnostics (Segment)(IVD)Market SegmentsTests performed on biological samples outside the body to inform diagnosis or treatment.
- In-House IVDs (Article 5(5))RegulatoryDevices manufactured and used within a single EU health institution under conditions in IVDR Article 5(5).
- Incremental Cost-Effectiveness Ratio(ICER)ReimbursementCost per additional unit of health outcome (often QALY) versus comparator.
- Indications for Use(IFU (statement))RegulatoryDescription of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate.
- Industry Trade OrganizationsIndustry BodiesAssociations representing MedTech manufacturers in policy, reimbursement, and standards.
- Information Sharing and Analysis Organization(ISAO)Industry BodiesA self-organized entity, authorized under the Cybersecurity Act of 2015, that gathers, analyzes, and shares cybersecurity threat information among members, including in the health sector.
- Informed ConsentClinical & TrialsVoluntary, informed agreement to participate in research after disclosure of risks and benefits.
- Initial Public Offering(IPO)Investment & FinanceFirst sale of a company's stock to public investors via a registered SEC offering, typically on NYSE or Nasdaq.
- Inpatient Prospective Payment System(IPPS)ReimbursementMedicare's payment system for inpatient hospital stays.
- Institutional Review Board(IRB)Clinical & TrialsBoard that reviews and approves human-subjects research at an institution.
- Instructions for Use(IFU)RegulatoryInformation supplied by the manufacturer to inform the user of safe use of a device.
- Integrated Delivery Network(IDN)CommercializationNetwork of healthcare facilities under common ownership or affiliation.
- Intended UseRegulatoryThe objective intent of the manufacturer regarding the use of the device.
- Intent-to-Treat vs Per-Protocol(ITT / PP)Clinical & TrialsTwo analysis populations: ITT analyzes everyone randomized; PP analyzes only those compliant with protocol.
- Internal AuditQuality & RiskPlanned, independent evaluation of QMS conformity and effectiveness.
- InteroperabilitySoftware & AIAbility of devices and systems to exchange and use information.
- Investigational Device Exemption(IDE)Clinical & TrialsFDA authorization to use an investigational device in a clinical study.
- Investigator Brochure(IB)Clinical & TrialsCompilation of clinical and nonclinical information on an investigational device given to clinical investigators, establishes what's 'anticipated' for UADE determinations.
- Investigator-Initiated Trial(IIT)Clinical & TrialsA clinical trial where an individual investigator (typically academic), not the device or drug manufacturer, holds the regulatory sponsor role and is responsible for IRB, IDE/IND, and conduct.
- IQ / OQ / PQQuality & RiskInstallation, Operational, and Performance Qualification - the three stages of equipment and process qualification.
- ISO 10993-1StandardsBiological evaluation of medical devices within a risk management process.
- ISO 11135StandardsStandard for development, validation, and routine control of ethylene oxide (EO) sterilization.
- ISO 11137StandardsStandard for radiation sterilization of healthcare products.
- ISO 11607-1/-2StandardsStandards for sterile barrier systems for terminally sterilized medical devices.
- ISO 13485StandardsInternational standard for medical device quality management systems.
- ISO 14155StandardsGood clinical practice for clinical investigations of medical devices.
- ISO 14971StandardsInternational standard for the application of risk management to medical devices.
- ISO 15223-1 SymbolsStandardsRecognized graphical symbols for labels, labeling, and information supplied with medical devices.
- ISO 17511StandardsISO standard specifying requirements for establishing metrological traceability of values assigned to calibrators, controls, and human samples for IVD measurement procedures.
- ISO 17665StandardsStandard for moist heat (steam) sterilization of medical devices.
- ISO 20417StandardsStandard for information to be supplied by the manufacturer of medical devices.
- ISO 20916RegulatoryInternational standard for Good Study Practice for clinical performance studies of IVDs using specimens from human subjects.
- ISO 22301StandardsStandard for business continuity management systems.
- ISO 31000Quality & RiskGeneric enterprise risk management standard; complements ISO 14971's product risk focus.
- ISO/IEC 23894StandardsGuidance on AI-specific risk management for organizations developing or using AI systems.
- ISO/IEC 27001(ISO 27001)CybersecurityInternational standard for information security management systems (ISMS), often required of MedTech vendors by enterprise customers.
- ISO/TR 24971StandardsGuidance on the application of ISO 14971 to medical devices.
- IVDR Conformity Assessment RoutesRegulatoryThe Annex IX, X, and XI procedures a manufacturer chooses to demonstrate IVDR compliance based on device class.
- IVDR Legacy DeviceRegulatoryAn IVD lawfully placed on the market under IVDD 98/79/EC that continues to be supplied under IVDR transitional provisions.
- IVDR Performance EvaluationRegulatoryContinuous, systematic process to generate, collect, analyse, and assess data demonstrating an IVD's performance under IVDR Article 56.
- IVDR Risk Classes A–DRegulatoryEU IVDR's risk-based classification: Class A (lowest) to Class D (highest).
- IVDR Transitional ProvisionsRegulatoryExtended deadlines under Regulation (EU) 2024/1860 allowing legacy IVDs to remain on the market until 2027 to 2029 based on class.
K1 term
L16 terms
- Label ClaimsCommercializationIndications, performance, and other statements approved or cleared for labeling.
- LabelingRegulatoryAll written, printed, or graphic matter on or accompanying a device.
- Laboratory-Developed Test(LDT)Market SegmentsIVD designed, manufactured, and used within a single CLIA laboratory.
- Launch ReadinessCommercializationCross-functional checklist confirming a product is ready for commercial release.
- LCD and NCDReimbursementLocal and National Coverage Determinations from Medicare.
- Legacy Device CybersecurityCybersecurityCybersecurity considerations for medical devices that cannot be reasonably protected against current threats.
- Letter to File(LTF)RegulatoryInternal documentation justifying that a device change does not require a new 510(k) submission.
- Limit of Detection / Limit of Quantitation(LoD / LoQ)Clinical & TrialsLowest analyte concentrations an assay can reliably detect (LoD) or quantify (LoQ).
- Limited Partner / General Partner(LP / GP)Investment & FinanceThe two principal roles in a venture capital fund: LPs provide capital, GPs manage the fund and make investment decisions.
- LINDDUNCybersecurityPrivacy threat modeling framework that decomposes privacy threats into seven categories, the privacy counterpart to STRIDE.
- Liquidation PreferenceInvestment & FinanceRight of preferred shareholders to be paid before common in an exit.
- Liquidity EventInvestment & FinanceAny transaction that converts illiquid private-company equity into cash or freely tradable securities, typically IPO, M&A, or secondary tender.
- Lock-Up PeriodInvestment & FinanceA contractually specified period after an IPO or acquisition during which insiders and pre-existing stockholders are restricted from selling their shares.
- Locked vs. Adaptive AlgorithmSoftware & AIDistinction between models whose behavior is fixed at release vs. those that continue learning.
- Lost to Follow-upClinical & TrialsSubjects whose outcome data are missing because they did not complete planned visits.
- Lot TraceabilityManufacturingAbility to trace materials, processes, and devices forward and backward through the supply chain by lot number.
M39 terms
- Managed Service / Reagent RentalCommercializationMulti-year contract where instrument cost is bundled into per-test pricing.
- Management RepresentativeQuality & RiskMember of management appointed to ensure QMS processes are established and report on QMS performance.
- Management ReviewQuality & RiskTop-management evaluation of QMS performance at planned intervals.
- Manufacturer Disclosure Statement for Medical Device Security(MDS2)CybersecurityA standardized form by which device manufacturers disclose security characteristics to healthcare delivery organizations.
- Manufacturer Incident Report(MIR)Post-MarketStandardized EU vigilance report submitted to competent authorities via EUDAMED.
- Master Protocol (Basket / Umbrella / Platform)Clinical & TrialsA single protocol that evaluates multiple interventions, populations, or sub-studies under a unified statistical and operational framework.
- MDR Article 117RegulatoryEU MDR provision adding device-component requirements to the EU pharma marketing authorization process.
- MedhackingCybersecurityUmbrella term for hacking activity directed at medical devices, ranging from criminal attack to coordinated security research and patient-led modification.
- Medical Device Coordination Group Guidance(MDCG)RegulatoryGuidance documents from the EU-level expert group that interpret MDR/IVDR requirements.
- Medical Device Data System(MDDS)Software & AIHardware or software intended to transfer, store, convert format, or display medical device data, generally not actively regulated by FDA after 2017 Cures Act amendments.
- Medical Device Innovation Consortium(MDIC)Industry BodiesPublic-private partnership to advance medical device regulatory science.
- Medical Device RecallPost-MarketRemoval or correction of a marketed device that violates FDA law.
- Medical Device Reporting (FDA)(MDR)Post-MarketFDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions.
- Medical Device Single Audit Program(MDSAP)Quality & RiskSingle audit of a manufacturer's QMS satisfying multiple participating regulators.
- Medical Device User Fee Amendments(MDUFA)RegulatoryStatutory framework setting FDA device user fees and corresponding performance commitments, reauthorized every five years.
- Medical Device VigilancePost-MarketReporting and management of serious incidents and field safety corrective actions.
- Medical ImagingMarket SegmentsDevices that produce images of the body for diagnosis or guidance.
- Medicare Administrative Contractor(MAC)ReimbursementPrivate contractors that process Medicare Part A/B and DME claims and issue Local Coverage Determinations within their jurisdictions.
- Medicare Physician Fee Schedule(MPFS)ReimbursementMedicare's payment system for physician professional services.
- MedjackingCybersecurityCompromise of a networked medical device to use it as a foothold inside a hospital network or to manipulate clinical function.
- MedTech Accelerators and IncubatorsIndustry BodiesPrograms providing capital, mentorship, and infrastructure to early-stage MedTech companies.
- MedTech InnovatorIndustry BodiesLargest non-profit accelerator and competition program for MedTech startups.
- Mergers and Acquisitions(M&A)Investment & FinanceTransactions in which one company acquires or combines with another, the dominant MedTech exit path, typically a strategic acquisition by an established player.
- Metrological Traceability (IVDR)RegulatoryAnnex I Section 9.4 requirement that values assigned to calibrators and controls are traceable to higher-order reference materials or procedures.
- MHRA / UKCA Marking(MHRA / UKCA)RegulatoryUK regulator and post-Brexit conformity marking for medical devices in Great Britain.
- Milestone PaymentInvestment & FinanceContingent payment triggered by a defined event in a partnership, M&A, or financing.
- Milestone-Based TrancheInvestment & FinanceInvestment paid in installments triggered by predefined milestones.
- Minimal Clinically Important Difference(MCID)Clinical & TrialsSmallest change in a measurement that patients perceive as clinically meaningful.
- Ministry of Food and Drug Safety (Korea)(MFDS)RegulatorySouth Korea's regulator for foods, drugs, cosmetics, and medical devices.
- MITRE ATT&CK(ATT&CK)CybersecurityKnowledge base of real-world adversary tactics, techniques, and procedures organized into a matrix used to model threats and assess defenses.
- MITRE D3FEND(D3FEND)CybersecurityMITRE's knowledge graph of defensive cybersecurity countermeasures, explicitly mapped to the ATT&CK techniques they mitigate.
- MLOps for Medical Devices(MLOps)Software & AIThe set of practices and tooling for deploying, monitoring, retraining, and governing machine learning models in regulated medical device software environments.
- Model CardSoftware & AIStructured documentation of a machine learning model's intended use, performance, and limitations.
- Model Drift MonitoringSoftware & AIOngoing surveillance of input data and model outputs to detect performance degradation post-deployment.
- Modular PMARegulatoryPMA submission strategy where a manufacturer submits portions of the PMA (modules) sequentially as they become ready, rather than as a single complete application.
- MolDx ProgramReimbursementA Medicare molecular diagnostics program, administered by Palmetto GBA and adopted by several Medicare Administrative Contractors, that technically assesses molecular tests and assigns Z-codes for claims processing and local coverage.
- Molecular DiagnosticsMarket SegmentsIVDs that detect nucleic acids - DNA or RNA - to diagnose disease.
- MRP and ERP Systems(MRP / ERP)ManufacturingMaterial Requirements Planning and Enterprise Resource Planning systems that orchestrate MedTech production and supply chain.
- MS-DRG(MS-DRG)ReimbursementMedicare's inpatient hospital payment classification system.
N13 terms
- National and Local Coverage Determinations(NCD / LCD)ReimbursementMedicare coverage policies issued nationally (NCD) or by individual MAC contractors (LCD).
- National Medical Products Administration(NMPA)RegulatoryChina's regulatory authority for drugs, medical devices, and cosmetics.
- NeuromodulationMarket SegmentsImplantable devices that stimulate the nervous system to treat disease.
- New Technology Add-On Payment(NTAP)ReimbursementSupplemental Medicare payment for inpatient use of qualifying new technologies.
- NIST Cybersecurity Framework(NIST CSF)CybersecurityA risk-based framework of cybersecurity functions and outcomes published by NIST and widely used to organize MedTech security programs.
- NIST IR 8473, Cybersecurity Framework Profile for HPH(NIST IR 8473)CybersecurityNIST's Cybersecurity Framework profile tailored to the Healthcare and Public Health sector, translates NIST CSF outcomes into HPH-specific subcategories and references.
- NIST SP 800-53 / 800-171(NIST 800-53/171)CybersecurityFederal control catalogs (800-53) and CUI-handling requirements (800-171) often referenced in MedTech contracts.
- NMPA Innovative Medical Device PathwayRegulatoryChina NMPA priority pathway for innovative devices with domestic IP and clinical advantage.
- Non-Dilutive FundingInvestment & FinanceCapital that does not require giving up equity, such as grants or debt.
- Non-Inferiority TrialClinical & TrialsA trial designed to demonstrate that a new intervention is not worse than an active comparator by more than a pre-specified, clinically acceptable margin.
- Nonconformance (NCR)(NCR)Quality & RiskFailure of a product, process, or system to meet specified requirements.
- Notified Body(NB)RegulatoryEU-designated organization that assesses conformity of medical devices under MDR and IVDR.
- Notified Body Scrutiny (IVDR Class D)RegulatoryAdditional expert-panel review of a notified body's assessment for certain novel or high-risk Class D devices before certification.
O7 terms
- Off-Label UseCommercializationUse of a device for an indication not in its cleared/approved labeling.
- ONC HTI-1 / HTI-2Software & AIONC certification rules adding transparency and risk-management requirements to certified health IT, including AI/predictive DSI.
- Ophthalmology DevicesMarket SegmentsDevices for diagnosis and treatment of eye conditions.
- Orthopedic DevicesMarket SegmentsImplants and instruments for bone, joint, and spine conditions.
- Outpatient Prospective Payment System(OPPS)ReimbursementMedicare's payment system for hospital outpatient services.
- Over-the-Air Updates(OTA)CybersecurityRemote, network-delivered software or firmware updates to a fielded medical device.
- OWASP IoT and Embedded Application SecurityCybersecurityOWASP project resources for securing IoT, embedded, and connected medical devices.
P51 terms
- PatchabilityCybersecurityThe designed-in ability to deploy security updates to a fielded medical device in a timely, controlled, and verifiable manner.
- Patient MonitoringMarket SegmentsBedside and wearable systems that continuously measure vital signs (ECG, SpO2, NIBP, capnography, temperature) and route alarms to clinicians.
- Pay-to-Play ProvisionInvestment & FinanceA charter or agreement provision that penalizes existing preferred stockholders (often by converting their preferred to common) if they do not participate pro rata in a future down round.
- Penetration TestingCybersecurityHands-on adversarial testing in which qualified independent testers attempt to exploit a device's security controls.
- Performance Study (IVDR)Clinical & TrialsA study to establish or confirm analytical or clinical performance of an IVD, governed by IVDR Articles 57 to 77.
- Performance Study Application (IVDR)RegulatoryFormal submission via EUDAMED required before commencing certain performance studies under IVDR Annex XIII and XIV.
- Periodic Safety Update Report(PSUR)Post-MarketPeriodic EU MDR/IVDR report summarizing post-market surveillance findings.
- Person Responsible for Regulatory Compliance(PRRC)RegulatoryNamed individual required by EU MDR/IVDR Article 15 with regulatory responsibility inside the manufacturer.
- Pharmaceuticals and Medical Devices Agency(PMDA)RegulatoryJapan's regulatory authority for medical devices, drugs, and regenerative medicine.
- Pharmacogenomics(PGx)Clinical & TrialsThe study of how genetic variation affects an individual's response to drugs, used to guide dosing, drug selection, and companion diagnostic development.
- PHI and ePHICybersecurityIndividually identifiable health information (PHI) and its electronic form (ePHI) - the data class HIPAA protects.
- Physician Payments Sunshine ActCommercializationU.S. law requiring disclosure of payments to physicians and teaching hospitals.
- Physician Training and ProctoringCommercializationStructured education and supervised cases for physicians adopting a new device.
- Pivotal TrialClinical & TrialsDefinitive clinical study designed to establish safety and effectiveness for marketing authorization.
- PMA Supplement TypesRegulatoryFDA's five-way taxonomy for post-approval PMA changes, Panel-Track, 180-Day, Real-Time, Special, and 30-Day Notice, each with distinct content and timing.
- Point-of-Care Diagnostics(POC)Market SegmentsDiagnostic tests performed near the patient, outside a central lab.
- Post-Market Clinical Follow-up(PMCF)Post-MarketProactive collection of clinical data on a CE-marked device to confirm safety and performance.
- Post-Market Performance Follow-up(PMPF)Post-MarketThe IVDR counterpart of PMCF: ongoing collection and analysis of performance data after CE certification.
- Post-Market Performance Follow-Up (IVDR)(PMPF)RegulatoryContinuous process of proactively collecting and evaluating performance data on an IVD after CE marking, analogous to MDR PMCF.
- Post-Market Surveillance(PMS)Post-MarketActivities to monitor device safety and performance after market release.
- Post-Market Surveillance PlanPost-MarketDocumented plan describing PMS activities, data sources, methods, and review frequency.
- Post-Market Surveillance Plan (IVDR)RegulatoryManufacturer-maintained plan under Article 79 describing how safety and performance data are systematically collected once an IVD is on the market.
- Post-Money ValuationInvestment & FinanceCompany valuation immediately after a financing closes.
- Post-Production Information (Risk)Quality & RiskISO 14971 requirement to feed real-world post-market data back into the risk management process.
- Postmarket Cybersecurity ManagementCybersecurityFDA's framework for ongoing vulnerability monitoring, risk assessment, and remediation of medical device cybersecurity issues after a device is on the market.
- Pragmatic TrialClinical & TrialsA trial designed to evaluate effectiveness in usual-care settings, using broad eligibility, routine workflows, and outcomes meaningful to patients and payers.
- Pre-Approval Inspection(PAI)ManufacturingFDA inspection of a manufacturing facility prior to PMA approval.
- Pre-Money ValuationInvestment & FinanceCompany valuation immediately before new money is invested.
- Pre-Submission Meeting(Q-Sub)CommercializationFormal FDA feedback request prior to a marketing or IDE submission.
- Predetermined Change Control Plan(PCCP)Software & AIFDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices.
- Predetermined Maintenance vs PCCPSoftware & AIDistinction between routine maintenance changes (cybersecurity patches, minor fixes) and PCCP-controlled algorithm changes.
- Predicate DeviceRegulatoryA legally marketed device used as the comparator in a 510(k) submission.
- Preferred StockInvestment & FinanceClass of equity with rights superior to common stock.
- Premarket Approval(PMA)RegulatoryFDA's most stringent device marketing application, required for high-risk Class III devices.
- Premarket Cybersecurity SubmissionCybersecurityThe bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device.
- Priced RoundInvestment & FinanceAn equity financing in which the company and investors agree on a per-share price and issue preferred stock, as opposed to a convertible note or SAFE.
- Primary and Secondary EndpointsClinical & TrialsThe pre-specified outcomes that determine trial success (primary), provide supporting evidence (secondary), or generate hypotheses (exploratory).
- Prior AuthorizationReimbursementPayer requirement for approval before a service or device is covered.
- Pro-Rata RightsInvestment & FinanceRight of an existing investor to maintain ownership percentage in future rounds.
- Process Capability (Cp/Cpk) and SPCManufacturingStatistical metrics and methods for monitoring whether a process meets its specifications.
- Process Capability and CpkManufacturingStatistical measures (Cp, Cpk, Pp, Ppk) of how well a process output fits within specification limits.
- Process FMEA vs Design FMEA(PFMEA / DFMEA)Quality & RiskTwo FMEA flavors: DFMEA analyzes design failure modes; PFMEA analyzes manufacturing process failure modes.
- Process ValidationManufacturingEstablishing documented evidence that a process consistently produces conforming output.
- Production and Process ControlsQuality & Risk21 CFR 820.70 / ISO 13485 §7.5 requirements that production processes be planned, controlled, monitored, and validated where needed.
- Propensity Score MethodsClinical & TrialsStatistical techniques (matching, weighting, stratification) to balance baseline characteristics in observational comparisons.
- Proprietary Laboratory Analyses Codes(PLA)ReimbursementAMA CPT code subset that uniquely identifies a single proprietary clinical lab test (LDT or IVD) for pricing and tracking.
- Protecting Access to Medicare Act(PAMA)ReimbursementLaw that revised Medicare pricing for clinical lab services.
- Protective ProvisionsInvestment & FinanceVeto rights held by preferred stockholders (usually voting as a class) over specified corporate actions, negotiated in the certificate of incorporation.
- Protocol DeviationClinical & TrialsDeparture from the approved clinical investigation plan.
- Provider and Deployer (EU AI Act)RegulatoryThe two primary role categories in the AI Act. Providers place systems on the market; deployers put them into use in a professional capacity.
- PSUR (IVDR Specific)Post-MarketPeriodic Safety Update Report obligations for IVDs under EU IVDR Article 81.
Q6 terms
- Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub)RegulatoryVoluntary mechanism to obtain FDA feedback before a formal premarket submission.
- Quality Management System(QMS)Quality & RiskThe organizational structure, processes, and resources a manufacturer implements to consistently design, manufacture, and support devices meeting regulatory and quality requirements.
- Quality Management System Regulation(QMSR)Quality & RiskFDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference.
- Quality ManualQuality & RiskTop-level QMS document describing scope, processes, and their interactions.
- Quality System Regulation(QSR / 21 CFR 820)Quality & RiskFDA's current good manufacturing practice (cGMP) requirements for medical devices.
- Quality-Adjusted Life Year(QALY)ReimbursementOutcome metric combining length and quality of life used in HTA.
R20 terms
- Razor / Razor-Blade ModelCommercializationSell capital equipment at low margin; recurring consumables drive profit.
- Real-Time PMA Supplement ReviewRegulatoryExpedited PMA supplement review pathway where FDA and the manufacturer meet to review minor device or labeling changes in real time.
- Real-World Data(RWD)Clinical & TrialsData relating to patient health status or care delivery routinely collected from sources other than traditional clinical trials, the inputs from which Real-World Evidence is derived.
- Real-World Evidence(RWE)Clinical & TrialsClinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data.
- Recovery Audit Contractor(RAC)ReimbursementCMS contractor that audits Medicare claims for improper payments.
- Refuse to Accept(RTA)RegulatoryFDA administrative decision that a submission is incomplete and won't be substantively reviewed.
- Refuse to Accept (Cybersecurity)(RTA (cyber))CybersecurityFDA's authority to reject a premarket submission outright when required cybersecurity content is missing.
- Regulatory Affairs Professionals Society(RAPS)Industry BodiesGlobal professional society for regulatory affairs across health-product industries.
- Remote Patient Monitoring(RPM)Market SegmentsDevices and services that capture patient data outside clinical settings.
- Removal vs Correction (21 CFR 806)Post-MarketReporting categories for field actions: removal physically retrieves the device; correction modifies it in place.
- Renal Care DevicesMarket SegmentsDevices for hemodialysis, peritoneal dialysis, and continuous renal replacement therapy in ESRD and AKI patients.
- Request for Designation(RFD)RegulatoryFormal mechanism to obtain a binding FDA decision on which Center will regulate a product.
- Respiratory DevicesMarket SegmentsDevices for managing breathing and airway conditions.
- Risk Acceptability MatrixQuality & RiskPre-defined matrix mapping severity × probability combinations to acceptable, ALARP, or unacceptable risk.
- Risk ManagementQuality & RiskThe lifecycle process defined by ISO 14971 for identifying, analyzing, evaluating, controlling, and monitoring risks associated with a medical device throughout its life cycle.
- Risk Management File(RMF)Quality & RiskSet of records and outputs from the ISO 14971 risk management process.
- Risk-Based Monitoring(RBM)Clinical & TrialsMonitoring strategy that targets oversight resources to the highest-risk sites, processes, and data based on a documented risk assessment, replacing 100% source data verification.
- Royalty FinancingInvestment & FinanceNon-dilutive capital exchanged for a royalty (typically a percentage of revenue) on a defined product or product family, usually with a capped multiple of invested capital.
- RunwayInvestment & FinanceMonths of operating cash a company has before running out.
- RWE for ReimbursementReimbursementReal-world evidence used to support coverage and payment decisions.
S58 terms
- Safer Technologies Program(STeP)RegulatoryFDA program for devices addressing less serious conditions but offering meaningful safety improvements.
- Sample Size and Statistical PowerClinical & TrialsPre-trial calculation of the number of subjects needed to detect a specified treatment effect with acceptable Type I and Type II error rates.
- SAST and DASTCybersecurityAutomated security testing - SAST analyzes source code at rest, DAST exercises a running application.
- Saudi Food and Drug Authority(SFDA)RegulatorySaudi Arabian medical device regulator; central authority for the GCC reliance pathway.
- SBIR / STTR Grants(SBIR/STTR)Investment & FinanceU.S. federal small-business R&D grants from agencies including NIH and DoD.
- Scientific Validity (IVDR)RegulatoryThe association of an analyte with a clinical condition or physiological state.
- Scrap Rate and YieldManufacturingProduction metrics tracking material loss (scrap) and the proportion of acceptable output (yield).
- Section 522 Postmarket Surveillance(Section 522)Post-MarketFDA's authority to order manufacturers to conduct post-market surveillance studies on certain Class II or Class III devices.
- Section 524B of the FD&C Act(524B)CybersecurityThe federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices.
- Secure BootCybersecurityA chain-of-trust mechanism that ensures only cryptographically signed firmware and software can run on a device.
- Secure Product Development Framework(SPDF)CybersecurityA documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle.
- Secure Software Development Framework(SSDF)CybersecurityNIST SP 800-218, a framework of secure software development practices that is referenced by EO 14028 and increasingly by medical device guidance.
- Secure-by-Design (Devices)Software & AIEngineering principle of building security in from initial architecture rather than bolting it on.
- Self-Test and Near-Patient Testing (IVDR)RegulatoryIVDR categories for devices intended for use by lay persons (self-test) or outside a laboratory environment by healthcare professionals (near-patient).
- Series A / B / C Financing RoundsInvestment & FinanceSequential priced equity rounds in venture-backed companies, typically progressing from product-market validation (A) to scale (B) to growth (C+).
- Serious Adverse Event(SAE)Clinical & TrialsAdverse event resulting in death, life-threat, hospitalization, persistent disability, or congenital anomaly.
- Servicing (21 CFR 820.200)Quality & RiskQuality system requirements for servicing devices, including service report analysis as potential complaints.
- Sham ControlClinical & TrialsPlacebo-equivalent for device trials - a non-therapeutic procedure that mimics the investigational intervention.
- Shelf LifeQuality & RiskPeriod during which a device remains suitable for its intended use under specified conditions.
- Side-Channel AttackCybersecurityAn attack that extracts secrets by analyzing physical or timing signals rather than breaking cryptography directly.
- Simple Agreement for Future Equity(SAFE)Investment & FinanceConvertible instrument that converts to equity at a future priced round.
- Single-Use Device(SUD)Market SegmentsA device the original manufacturer labels for one use or one patient, distinct from reusable devices and from FDA-regulated reprocessed SUDs.
- Site-Neutral PaymentReimbursementMedicare payment policy that pays the same amount for a service regardless of whether it is delivered in a hospital outpatient department, ASC, or physician office.
- Sleep & Respiratory DevicesMarket SegmentsDevices for diagnosis and treatment of sleep-disordered breathing and chronic respiratory disease, CPAP, BiPAP, ventilators, and home sleep tests.
- SOC 2CybersecurityAICPA attestation report on a service organization's controls over Security, Availability, Processing Integrity, Confidentiality, and Privacy, the standard SaaS trust artifact.
- Software as a Medical Device(SaMD)Software & AISoftware intended for medical purposes that performs without being part of a hardware device.
- Software Bill of Materials(SBOM)CybersecurityA machine-readable inventory of all software components, including open-source and third-party libraries, used to build a medical device.
- Software in a Medical Device(SiMD)Software & AISoftware embedded in or required to operate a hardware medical device.
- Software Maintenance PlanSoftware & AIIEC 62304 §6 documented plan for handling problem reports, changes, and releases over the software lifecycle.
- Software of Unknown Provenance(SOUP)Software & AISoftware not developed for medical device use, or lacking adequate development records, incorporated into a device.
- Software Safety CaseCybersecurityA structured argument, supported by evidence, that a device's software is acceptably safe (and increasingly, secure) for its intended use.
- Software Safety ClassificationSoftware & AIIEC 62304 classes A, B, C reflecting potential harm from software failure.
- Source Data Verification(SDV)Clinical & TrialsProcess of comparing data in case report forms against original source records.
- SPDX(SPDX)CybersecurityAn open SBOM and license-data format published as ISO/IEC 5962:2021.
- Special 510(k)(Special 510(k))RegulatoryStreamlined 510(k) for modifications to a manufacturer's own legally marketed device.
- Special ControlsRegulatoryDevice-type-specific FDA requirements (often performance standards, labeling, or post-market surveillance) that apply on top of General Controls.
- Special Purpose Acquisition Company(SPAC)Investment & FinanceA publicly traded shell company formed to raise capital through an IPO with the sole purpose of acquiring or merging with a private operating company.
- Specialty MedTech Venture CapitalIndustry BodiesVC firms with dedicated MedTech practices and operating expertise in regulated device development.
- SpineMarket SegmentsDevices for spinal fusion, deformity correction, and motion preservation.
- Stability TestingManufacturingStudies that establish how device performance and packaging hold up over time.
- Stark LawCommercializationFederal law restricting physician self-referral for designated health services.
- SterilizationManufacturingValidated process used to render a device free from viable microorganisms.
- Strategic AcquisitionCommercializationPurchase of a company by a strategic buyer, typically a larger MedTech.
- Strategic InvestorInvestment & FinanceCorporate investor with operational, not just financial, motives.
- STRIDE Threat Model(STRIDE)CybersecurityA six-category framework for enumerating threats: Spoofing, Tampering, Repudiation, Information disclosure, Denial of service, Elevation of privilege.
- Structural HeartMarket SegmentsTranscatheter therapies for valvular and structural heart disease.
- Substantial Equivalence(SE)RegulatoryThe legal standard a 510(k) device must meet versus a predicate.
- Summary of Safety and Clinical Performance(SSCP)RegulatoryPublic-facing summary required for high-risk and implantable devices under EU MDR.
- Summary of Safety and Performance (IVDR)(SSP)RegulatoryPublicly accessible summary that manufacturers of Class C and D IVDs must prepare and upload to EUDAMED.
- Summative vs. Formative EvaluationQuality & RiskIterative usability studies (formative) vs. final validation testing (summative) of a device's user interface.
- Super Pro Rata RightsInvestment & FinanceA contractual right allowing an investor to purchase more than its current ownership percentage in a future financing round, beyond a standard pro-rata right.
- Supplier ControlsManufacturingProcedures to ensure purchased products and services conform to requirements.
- Supply-chain Levels for Software Artifacts(SLSA)CybersecurityOpenSSF framework defining progressive levels of build-system integrity for software supply chain security, focused on tamper-resistance of the build.
- Surgical RoboticsMarket SegmentsRobotic systems that assist surgeons in performing operations.
- Surrogate EndpointClinical & TrialsBiomarker or intermediate outcome used as a substitute for a clinical endpoint in regulatory decisions.
- SwissmedicRegulatorySwiss medical device regulator; Switzerland is now a third country to the EU under MDR.
- Synthetic DataSoftware & AIArtificially generated data used to augment training, validation, or stress-testing of medical AI.
- Systemic Risk (GPAI)RegulatoryAdditional AI Act tier for GPAI models above a compute threshold or otherwise designated as posing systemic risk.
T15 terms
- TAM / SAM / SOMCommercializationMarket sizing framework: total, serviceable available, and serviceable obtainable.
- Technical DocumentationRegulatoryThe dossier of design, manufacturing, risk, and clinical/performance evidence a manufacturer compiles under MDR/IVDR Annexes II and III to demonstrate conformity.
- Technology Transfer (Manufacturing)ManufacturingTransfer of validated processes and knowledge from development (or one site) to commercial manufacturing.
- Term SheetInvestment & FinanceNon-binding outline of the key economic and control terms of an investment.
- Texas Medical Center Innovation(TMC Innovation)Industry BodiesHouston-based academic MedTech and digital health accelerator and incubator.
- Therapeutic Goods Administration(TGA)RegulatoryAustralia's regulator for therapeutic goods including medical devices and IVDs.
- Third-Party Review of 510(k)(3P 510(k))RegulatoryProgram in which FDA-accredited third parties conduct the initial 510(k) review for eligible device types.
- Threat ModelingCybersecurityA structured analysis that identifies how an attacker could compromise a medical device and what controls mitigate each threat.
- Total Product Lifecycle(TPLC)Software & AIFDA framework integrating premarket and post-market oversight across a device's life.
- Training RecordsQuality & RiskDocumented evidence personnel have the education, training, and experience for assigned tasks.
- Tranched FinancingInvestment & FinanceFinancing committed in stages tied to predefined milestones.
- Transitional Coverage for Emerging Technologies(TCET)ReimbursementCMS pathway providing time-limited Medicare coverage for FDA-designated Breakthrough Devices.
- Transitional Pass-Through Payment(TPT)ReimbursementSupplemental outpatient payment for new device technologies.
- Trend Reporting (MDR/MIR)Post-MarketObligation to report statistically significant increases in expected non-serious incidents.
- Trial Master File(TMF)Clinical & TrialsThe collection of essential documents that demonstrates the conduct of a clinical trial complies with GCP and applicable regulatory requirements.
U9 terms
- UDI-DI vs. UDI-PIManufacturingStatic device identifier (DI) vs. dynamic production identifier (PI) within a UDI.
- UK Responsible Person(UKRP)RegulatoryUK-based equivalent of the EU Authorized Representative required for non-UK manufacturers placing devices on the GB market.
- Unanticipated Adverse Device Effect(UADE)Clinical & TrialsAny serious adverse effect on health or safety in an IDE study not previously identified in the investigational plan, triggers strict reporting timelines.
- Unique Device Identification(UDI)RegulatorySystem for adequate identification of medical devices through distribution and use.
- Urology DevicesMarket SegmentsDevices for diagnosis and treatment of disorders of the urinary tract and male reproductive system, including BPH therapy, stone management, and continence devices.
- Usability EngineeringStandardsThe systematic process, defined in IEC 62366-1, for analyzing, specifying, designing, verifying, and validating the usability of a medical device to minimize use-related risk.
- Use ErrorClinical & TrialsUser action or lack thereof that leads to a different result than intended by the manufacturer or expected by the user.
- Use SpecificationQuality & RiskDefined description of intended users, uses, use environments, and patient populations for a device.
- Use-Related Risk Analysis(URRA)Quality & RiskAnalysis of use scenarios to identify potential use errors and their consequences.
V8 terms
- Validation Master Plan(VMP)Quality & RiskTop-level document describing the manufacturer's overall approach to qualification and validation activities.
- Valuation CapInvestment & FinanceMaximum company valuation at which a SAFE or note converts to equity.
- Value Analysis Committee(VAC)CommercializationHospital cross-functional committee that reviews and approves new product purchases.
- Value-Based Care(VBC)ReimbursementPayment tied to outcomes and total cost of care, not volume of services.
- Venture DebtInvestment & FinanceLoan made to a venture-backed company, usually alongside or after equity.
- Verification & Validation(V&V)Quality & RiskConfirming design outputs meet inputs (V) and that devices meet user needs (V).
- Vesting ScheduleInvestment & FinanceTimeline over which equity is earned by an employee or founder.
- Vulnerability Exploitability eXchange(VEX)CybersecurityA machine-readable statement that explains whether a known vulnerability is actually exploitable in a specific product.
W6 terms
- Warning LetterQuality & RiskFormal FDA notification of significant violations requiring prompt corrective action.
- Wearable Medical DevicesMarket SegmentsBody-worn devices that continuously monitor physiological signals.
- Wearables and Remote Patient Monitoring(RPM)Market SegmentsConnected devices that capture physiologic data outside traditional clinical settings.
- WHO Prequalification (Diagnostics)(WHO PQ Dx)RegulatoryWHO assessment of IVDs to support procurement by UN agencies and low- and middle-income countries.
- Women's Health DevicesMarket SegmentsDevices addressing reproductive health, pelvic floor, and OB/GYN care.
- Wound CareMarket SegmentsDevices and biologics for managing acute and chronic wounds.