Glossary
MedTech Glossary
Every term in the dictionary, listed alphabetically. Search by term, acronym, or category, then jump to a full definition.
489 of 489 terms
54 terms
A37 terms
- AAMI(AAMI)Industry Bodies
- AAMI SW96Cybersecurity
- AAMI TIR45(TIR45)Software & AI
- AAMI TIR57Cybersecurity
- AAMI TIR97(TIR97)Cybersecurity
- Abbreviated 510(k)Regulatory
- Accreditation Scheme for Conformity Assessment(ASCA)Regulatory
- Adaptive Trial DesignClinical & Trials
- Additional Condition for Nonprescription Use(ACNU)Regulatory
- AdvaMedIndustry Bodies
- AdvaMed Code of EthicsCommercialization
- AdvaMedDxIndustry Bodies
- Adversarial RobustnessSoftware & AI
- Adverse Event(AE)Clinical & Trials
- Advisory BoardCommercialization
- Aesthetic & Energy-Based DevicesMarket Segments
- AI Act Conformity Assessment (Medical Devices)Regulatory
- AI Act Post-Market MonitoringRegulatory
- AI Act Prohibited PracticesRegulatory
- AI Act Serious Incident ReportingRegulatory
- AI Act Technical Documentation (Annex IV)Regulatory
- AI Act Transparency ObligationsRegulatory
- AI Imaging SoftwareMarket Segments
- AI/ML-Enabled Medical DeviceSoftware & AI
- ALCOA+Clinical & Trials
- Algorithm Change Protocol(ACP)Software & AI
- Algorithmic Bias and FairnessSoftware & AI
- Ambulatory Payment Classification(APC)Reimbursement
- Analytical Performance (IVDR)Regulatory
- Analytical SensitivityClinical & Trials
- Annual Report (PMA)Post-Market
- Anti-Dilution ProtectionInvestment & Finance
- Anti-Kickback Statute(AKS)Commercialization
- ANVISA(ANVISA)Regulatory
- ASC Site-of-Service ShiftReimbursement
- ASTM F2503Standards
- Authorized Representative (EU)(EC REP)Regulatory
B14 terms
- Bayesian Trial DesignClinical & Trials
- Benefit-Risk DeterminationRegulatory
- Bill of Materials(BOM)Manufacturing
- BioburdenManufacturing
- BiocompatibilityQuality & Risk
- Blinding and MaskingClinical & Trials
- Bottom-Up Market SizingCommercialization
- BrainjackingCybersecurity
- Breakthrough Device Designation(BDD)Regulatory
- Bridge RoundInvestment & Finance
- Budget Impact Model(BIM)Reimbursement
- Bundled PaymentReimbursement
- Burn RateInvestment & Finance
- Burn Rate and RunwayInvestment & Finance
C44 terms
- CAPA Effectiveness CheckQuality & Risk
- Capitalization Table(Cap Table)Investment & Finance
- Cardiac Rhythm Management(CRM)Market Segments
- Cardiovascular DevicesMarket Segments
- Case Report Form(CRF)Clinical & Trials
- Category III CPT CodeReimbursement
- Category III CPT CodesReimbursement
- CE MarkRegulatory
- Change ControlQuality & Risk
- CISA Known Exploited Vulnerabilities Catalog(KEV)Cybersecurity
- Class D Batch Verification (IVDR)Regulatory
- Class III DeviceRegulatory
- Cleanroom Classes (ISO 14644)Manufacturing
- Clinical Decision Support(CDS)Software & AI
- Clinical Evaluation Plan(CEP)Clinical & Trials
- Clinical Evaluation Report(CER)Clinical & Trials
- Clinical Investigation Plan(CIP)Clinical & Trials
- Clinical Laboratory Improvement Amendments(CLIA)Market Segments
- Clinical Performance (IVDR)Regulatory
- CMS IDE Coverage (Category A & B)Reimbursement
- Code SigningCybersecurity
- Combination ProductRegulatory
- Common Specifications(CS)Regulatory
- Common Specifications (IVDR)(CS)Regulatory
- Common Vulnerabilities and Exposures(CVE)Cybersecurity
- Common Vulnerability Scoring System(CVSS)Cybersecurity
- Common Weakness Enumeration(CWE)Cybersecurity
- Companion Diagnostic(CDx)Market Segments
- Companion Diagnostic (IVDR)(CDx)Regulatory
- Complaint HandlingQuality & Risk
- Composite EndpointClinical & Trials
- Container Closure Integrity(CCI)Manufacturing
- Contract Research Organization(CRO)Industry Bodies
- Convertible NoteInvestment & Finance
- Coordinated Vulnerability Disclosure(CVD)Cybersecurity
- Corporate Venture Capital(CVC)Industry Bodies
- Corrective and Preventive Action(CAPA)Quality & Risk
- Counterfeit Parts and Suspect ComponentsManufacturing
- Coverage with Evidence Development(CED)Reimbursement
- CPT Codes(CPT)Reimbursement
- Cryptographic AgilityCybersecurity
- Current Procedural Terminology Codes(CPT)Reimbursement
- Customer Notification LetterPost-Market
- CycloneDXCybersecurity
D25 terms
- Data Governance (AI/ML)Software & AI
- Data Safety Monitoring Board(DSMB)Clinical & Trials
- Datasheets for DatasetsSoftware & AI
- De Novo Classification Request(De Novo)Regulatory
- De-Identification of Health DataCybersecurity
- Decentralized Clinical Trial(DCT)Clinical & Trials
- Dental DevicesMarket Segments
- Design ControlsQuality & Risk
- Design History File(DHF)Quality & Risk
- Design TransferManufacturing
- Device History Record(DHR)Manufacturing
- Device Master File(MAF)Regulatory
- Device Master Record(DMR)Manufacturing
- Device Reclassification PetitionRegulatory
- Diabetes CareMarket Segments
- Digital Therapeutic(DTx)Market Segments
- Digital Therapeutics(DTx)Market Segments
- DilutionInvestment & Finance
- Distributor vs Direct SalesCommercialization
- Document ControlQuality & Risk
- Down RoundInvestment & Finance
- Drag-Along and Tag-Along RightsInvestment & Finance
- Drug Delivery DevicesMarket Segments
- Due DiligenceInvestment & Finance
- Durable Medical Equipment, Prosthetics, Orthotics, and Supplies(DMEPOS)Reimbursement
E21 terms
- Early Feasibility Study(EFS)Clinical & Trials
- Earn-OutInvestment & Finance
- Electronic Data Capture(EDC)Clinical & Trials
- Electronic Instructions for Use(eIFU)Regulatory
- Electronic Medical Device Reporting(eMDR)Post-Market
- Electrophysiology(EP)Market Segments
- Emergency Use Authorization(EUA)Regulatory
- Employee Option PoolInvestment & Finance
- Endoscopy DevicesMarket Segments
- Endotoxin Testing (LAL)Manufacturing
- Engineering Change Order / Notice(ECO / ECN)Manufacturing
- ENT DevicesMarket Segments
- Essential PerformanceStandards
- eSTARRegulatory
- EU AI ActSoftware & AI
- EU In Vitro Diagnostic Regulation(IVDR)Regulatory
- EU Medical Device Regulation(MDR)Regulatory
- EU Reference Laboratory (EURL)(EURL)Regulatory
- EUDAMEDRegulatory
- Exit MultipleInvestment & Finance
- Explainability and InterpretabilitySoftware & AI
F16 terms
- Failure Mode and Effects Analysis(FMEA)Quality & Risk
- Fault Tree Analysis(FTA)Quality & Risk
- FDA Form 483Quality & Risk
- FDA Recall Classifications I, II, IIIPost-Market
- FDA Recognized Consensus StandardsRegulatory
- Feasibility StudyClinical & Trials
- Federated LearningSoftware & AI
- FedRAMP(FedRAMP)Cybersecurity
- Field Action vs RecallPost-Market
- Field Clinical Engineer(FCE)Commercialization
- Field Safety Corrective Action(FSCA)Post-Market
- First-in-Human Study(FIH)Clinical & Trials
- Fogarty InnovationIndustry Bodies
- Foundation Model (Healthcare)Software & AI
- Freedom to Operate(FTO)Commercialization
- Fundamental Rights Impact Assessment(FRIA)Regulatory
G10 terms
- General ControlsRegulatory
- General Safety and Performance Requirements(GSPRs)Regulatory
- General Safety and Performance Requirements (IVDR)(GSPR)Regulatory
- General-Purpose AI Model(GPAI)Regulatory
- Generative AI in Medical DevicesSoftware & AI
- Genetic Testing Requirements (IVDR Article 4)Regulatory
- Global Unique Device Identification Database(GUDID)Post-Market
- Good Clinical Practice(GCP)Commercialization
- Good Machine Learning Practice(GMLP)Software & AI
- Group Purchasing Organization(GPO)Commercialization
H19 terms
- Hardcoded CredentialsCybersecurity
- Hardware Root of Trust(HRoT)Cybersecurity
- Hazard, Hazardous Situation, and HarmQuality & Risk
- HCPCS Codes(HCPCS)Reimbursement
- Health Canada Medical Device Licence(MDL)Regulatory
- Health Economics and Outcomes Research(HEOR)Reimbursement
- Health Hazard Evaluation(HHE)Post-Market
- Health Industry Cybersecurity Practices(HICP)Cybersecurity
- Health Information Sharing and Analysis Center(H-ISAC)Cybersecurity
- Health Technology Assessment(HTA)Reimbursement
- Healthcare and Public Health Cybersecurity Performance Goals(HPH-CPG)Cybersecurity
- Hearing DevicesMarket Segments
- High-Risk AI System (EU AI Act)Regulatory
- HIPAA(HIPAA)Cybersecurity
- HITECH Act(HITECH)Cybersecurity
- HITRUST CSF(HITRUST)Cybersecurity
- HSCC Joint Security Plan(HSCC JSP)Cybersecurity
- Human Factors Engineering(HFE)Clinical & Trials
- Humanitarian Device Exemption(HDE)Regulatory
I58 terms
- ICD-10-CM / ICD-10-PCSReimbursement
- ICH E6 Good Clinical Practice(GCP)Clinical & Trials
- ICH E6(R3) Good Clinical Practice(E6(R3))Standards
- ICS Medical Advisory(ICSMA)Cybersecurity
- IDE Annual Progress ReportClinical & Trials
- IDE SupplementClinical & Trials
- IEC 60601-1Standards
- IEC 60601-1-2Standards
- IEC 60825Standards
- IEC 62304Standards
- IEC 62366-1Standards
- IEC 80001-1Cybersecurity
- IEC 81001-5-1Cybersecurity
- IEC 82304-1Standards
- IMDRFRegulatory
- IMDRF Principles and Practices for Medical Device CybersecurityCybersecurity
- Importer and Distributor Obligations (EU)Regulatory
- In Vitro Diagnostics(IVD)Market Segments
- In Vitro Diagnostics (Segment)(IVD)Market Segments
- In-House IVDs (Article 5(5))Regulatory
- Incremental Cost-Effectiveness Ratio(ICER)Reimbursement
- Indications for Use(IFU (statement))Regulatory
- Industry Trade OrganizationsIndustry Bodies
- Informed ConsentClinical & Trials
- Initial Public Offering(IPO)Investment & Finance
- Inpatient Prospective Payment System(IPPS)Reimbursement
- Institutional Review Board(IRB)Clinical & Trials
- Instructions for Use(IFU)Regulatory
- Integrated Delivery Network(IDN)Commercialization
- Intended UseRegulatory
- Intent-to-Treat vs Per-Protocol(ITT / PP)Clinical & Trials
- Internal AuditQuality & Risk
- InteroperabilitySoftware & AI
- Investigational Device Exemption(IDE)Clinical & Trials
- Investigator Brochure(IB)Clinical & Trials
- Investigator-Initiated Trial(IIT)Clinical & Trials
- IQ / OQ / PQQuality & Risk
- ISO 10993-1Standards
- ISO 11135Standards
- ISO 11137Standards
- ISO 11607-1/-2Standards
- ISO 13485Standards
- ISO 14155Standards
- ISO 14971Standards
- ISO 15223-1 SymbolsStandards
- ISO 17665Standards
- ISO 20417Standards
- ISO 20916Regulatory
- ISO 22301Standards
- ISO 31000Quality & Risk
- ISO/IEC 23894Standards
- ISO/IEC 27001(ISO 27001)Cybersecurity
- ISO/TR 24971Standards
- IVDR Conformity Assessment RoutesRegulatory
- IVDR Legacy DeviceRegulatory
- IVDR Performance EvaluationRegulatory
- IVDR Risk Classes A–DRegulatory
- IVDR Transitional ProvisionsRegulatory
L15 terms
- Label ClaimsCommercialization
- LabelingRegulatory
- Laboratory-Developed Test(LDT)Market Segments
- Launch ReadinessCommercialization
- LCD and NCDReimbursement
- Legacy Device CybersecurityCybersecurity
- Letter to File(LTF)Regulatory
- Limit of Detection / Limit of Quantitation(LoD / LoQ)Clinical & Trials
- Limited Partner / General Partner(LP / GP)Investment & Finance
- LINDDUNCybersecurity
- Liquidation PreferenceInvestment & Finance
- Liquidity EventInvestment & Finance
- Locked vs. Adaptive AlgorithmSoftware & AI
- Lost to Follow-upClinical & Trials
- Lot TraceabilityManufacturing
M38 terms
- Managed Service / Reagent RentalCommercialization
- Management RepresentativeQuality & Risk
- Management ReviewQuality & Risk
- Manufacturer Disclosure Statement for Medical Device Security(MDS2)Cybersecurity
- Manufacturer Incident Report(MIR)Post-Market
- Master Protocol (Basket / Umbrella / Platform)Clinical & Trials
- MDR Article 117Regulatory
- MedhackingCybersecurity
- Medical Device Coordination Group Guidance(MDCG)Regulatory
- Medical Device Data System(MDDS)Software & AI
- Medical Device Innovation Consortium(MDIC)Industry Bodies
- Medical Device RecallPost-Market
- Medical Device Reporting (FDA)(MDR)Post-Market
- Medical Device Single Audit Program(MDSAP)Quality & Risk
- Medical Device User Fee Amendments(MDUFA)Regulatory
- Medical Device VigilancePost-Market
- Medical ImagingMarket Segments
- Medicare Administrative Contractor(MAC)Reimbursement
- Medicare Physician Fee Schedule(MPFS)Reimbursement
- MedjackingCybersecurity
- MedTech Accelerators and IncubatorsIndustry Bodies
- MedTech InnovatorIndustry Bodies
- Mergers and Acquisitions(M&A)Investment & Finance
- Metrological Traceability (IVDR)Regulatory
- MHRA / UKCA Marking(MHRA / UKCA)Regulatory
- Milestone PaymentInvestment & Finance
- Milestone-Based TrancheInvestment & Finance
- Minimal Clinically Important Difference(MCID)Clinical & Trials
- Ministry of Food and Drug Safety (Korea)(MFDS)Regulatory
- MITRE ATT&CK(ATT&CK)Cybersecurity
- MITRE D3FEND(D3FEND)Cybersecurity
- MLOps for Medical Devices(MLOps)Software & AI
- Model CardSoftware & AI
- Model Drift MonitoringSoftware & AI
- Modular PMARegulatory
- Molecular DiagnosticsMarket Segments
- MRP and ERP Systems(MRP / ERP)Manufacturing
- MS-DRG(MS-DRG)Reimbursement
N13 terms
- National and Local Coverage Determinations(NCD / LCD)Reimbursement
- National Medical Products Administration(NMPA)Regulatory
- NeuromodulationMarket Segments
- New Technology Add-On Payment(NTAP)Reimbursement
- NIST Cybersecurity Framework(NIST CSF)Cybersecurity
- NIST IR 8473, Cybersecurity Framework Profile for HPH(NIST IR 8473)Cybersecurity
- NIST SP 800-53 / 800-171(NIST 800-53/171)Cybersecurity
- NMPA Innovative Medical Device PathwayRegulatory
- Non-Dilutive FundingInvestment & Finance
- Non-Inferiority TrialClinical & Trials
- Nonconformance (NCR)(NCR)Quality & Risk
- Notified Body(NB)Regulatory
- Notified Body Scrutiny (IVDR Class D)Regulatory
O7 terms
P46 terms
- PatchabilityCybersecurity
- Patient MonitoringMarket Segments
- Penetration TestingCybersecurity
- Performance Study (IVDR)Clinical & Trials
- Performance Study Application (IVDR)Regulatory
- Periodic Safety Update Report(PSUR)Post-Market
- Person Responsible for Regulatory Compliance(PRRC)Regulatory
- Pharmaceuticals and Medical Devices Agency(PMDA)Regulatory
- PHI and ePHICybersecurity
- Physician Payments Sunshine ActCommercialization
- Physician Training and ProctoringCommercialization
- Pivotal TrialClinical & Trials
- PMA Supplement TypesRegulatory
- Point-of-Care Diagnostics(POC)Market Segments
- Post-Market Clinical Follow-up(PMCF)Post-Market
- Post-Market Performance Follow-up(PMPF)Post-Market
- Post-Market Performance Follow-Up (IVDR)(PMPF)Regulatory
- Post-Market Surveillance(PMS)Post-Market
- Post-Market Surveillance PlanPost-Market
- Post-Market Surveillance Plan (IVDR)Regulatory
- Post-Money ValuationInvestment & Finance
- Post-Production Information (Risk)Quality & Risk
- Pragmatic TrialClinical & Trials
- Pre-Approval Inspection(PAI)Manufacturing
- Pre-Money ValuationInvestment & Finance
- Pre-Submission Meeting(Q-Sub)Commercialization
- Predetermined Change Control Plan(PCCP)Software & AI
- Predetermined Maintenance vs PCCPSoftware & AI
- Predicate DeviceRegulatory
- Preferred StockInvestment & Finance
- Premarket Approval(PMA)Regulatory
- Premarket Cybersecurity SubmissionCybersecurity
- Primary and Secondary EndpointsClinical & Trials
- Prior AuthorizationReimbursement
- Pro-Rata RightsInvestment & Finance
- Process Capability (Cp/Cpk) and SPCManufacturing
- Process Capability and CpkManufacturing
- Process FMEA vs Design FMEA(PFMEA / DFMEA)Quality & Risk
- Process ValidationManufacturing
- Production and Process ControlsQuality & Risk
- Propensity Score MethodsClinical & Trials
- Proprietary Laboratory Analyses Codes(PLA)Reimbursement
- Protecting Access to Medicare Act(PAMA)Reimbursement
- Protocol DeviationClinical & Trials
- Provider and Deployer (EU AI Act)Regulatory
- PSUR (IVDR Specific)Post-Market
Q5 terms
R19 terms
- Razor / Razor-Blade ModelCommercialization
- Real-Time PMA Supplement ReviewRegulatory
- Real-World Data(RWD)Clinical & Trials
- Real-World Evidence(RWE)Clinical & Trials
- Recovery Audit Contractor(RAC)Reimbursement
- Refuse to Accept(RTA)Regulatory
- Refuse to Accept (Cybersecurity)(RTA (cyber))Cybersecurity
- Regulatory Affairs Professionals Society(RAPS)Industry Bodies
- Remote Patient Monitoring(RPM)Market Segments
- Removal vs Correction (21 CFR 806)Post-Market
- Renal Care DevicesMarket Segments
- Request for Designation(RFD)Regulatory
- Respiratory DevicesMarket Segments
- Risk Acceptability MatrixQuality & Risk
- Risk Management File(RMF)Quality & Risk
- Risk-Based Monitoring(RBM)Clinical & Trials
- Royalty FinancingInvestment & Finance
- RunwayInvestment & Finance
- RWE for ReimbursementReimbursement
S57 terms
- Safer Technologies Program(STeP)Regulatory
- Sample Size and Statistical PowerClinical & Trials
- SAST and DASTCybersecurity
- Saudi Food and Drug Authority(SFDA)Regulatory
- SBIR / STTR Grants(SBIR/STTR)Investment & Finance
- Scientific Validity (IVDR)Regulatory
- Scrap Rate and YieldManufacturing
- Section 522 Postmarket Surveillance(Section 522)Post-Market
- Section 524B of the FD&C Act(524B)Cybersecurity
- Secure BootCybersecurity
- Secure Product Development Framework(SPDF)Cybersecurity
- Secure Software Development Framework(SSDF)Cybersecurity
- Secure-by-Design (Devices)Software & AI
- Self-Test and Near-Patient Testing (IVDR)Regulatory
- Series A / B / C Financing RoundsInvestment & Finance
- Serious Adverse Event(SAE)Clinical & Trials
- Servicing (21 CFR 820.200)Quality & Risk
- Sham ControlClinical & Trials
- Shelf LifeQuality & Risk
- Side-Channel AttackCybersecurity
- Simple Agreement for Future Equity(SAFE)Investment & Finance
- Single-Use Device(SUD)Market Segments
- Site-Neutral PaymentReimbursement
- Sleep & Respiratory DevicesMarket Segments
- SOC 2Cybersecurity
- Software as a Medical Device(SaMD)Software & AI
- Software Bill of Materials(SBOM)Cybersecurity
- Software in a Medical Device(SiMD)Software & AI
- Software Maintenance PlanSoftware & AI
- Software of Unknown Provenance(SOUP)Software & AI
- Software Safety CaseCybersecurity
- Software Safety ClassificationSoftware & AI
- Source Data Verification(SDV)Clinical & Trials
- SPDX(SPDX)Cybersecurity
- Special 510(k)(Special 510(k))Regulatory
- Special ControlsRegulatory
- Special Purpose Acquisition Company(SPAC)Investment & Finance
- Specialty MedTech Venture CapitalIndustry Bodies
- SpineMarket Segments
- Stability TestingManufacturing
- Stark LawCommercialization
- SterilizationManufacturing
- Strategic AcquisitionCommercialization
- Strategic InvestorInvestment & Finance
- STRIDE Threat Model(STRIDE)Cybersecurity
- Structural HeartMarket Segments
- Substantial Equivalence(SE)Regulatory
- Summary of Safety and Clinical Performance(SSCP)Regulatory
- Summary of Safety and Performance (IVDR)(SSP)Regulatory
- Summative vs. Formative EvaluationQuality & Risk
- Supplier ControlsManufacturing
- Supply-chain Levels for Software Artifacts(SLSA)Cybersecurity
- Surgical RoboticsMarket Segments
- Surrogate EndpointClinical & Trials
- SwissmedicRegulatory
- Synthetic DataSoftware & AI
- Systemic Risk (GPAI)Regulatory
T14 terms
- TAM / SAM / SOMCommercialization
- Technology Transfer (Manufacturing)Manufacturing
- Term SheetInvestment & Finance
- Texas Medical Center Innovation(TMC Innovation)Industry Bodies
- Therapeutic Goods Administration(TGA)Regulatory
- Third-Party Review of 510(k)(3P 510(k))Regulatory
- Threat ModelingCybersecurity
- Total Product Lifecycle(TPLC)Software & AI
- Training RecordsQuality & Risk
- Tranched FinancingInvestment & Finance
- Transitional Coverage for Emerging Technologies(TCET)Reimbursement
- Transitional Pass-Through Payment(TPT)Reimbursement
- Trend Reporting (MDR/MIR)Post-Market
- Trial Master File(TMF)Clinical & Trials
U8 terms
- UDI-DI vs. UDI-PIManufacturing
- UK Responsible Person(UKRP)Regulatory
- Unanticipated Adverse Device Effect(UADE)Clinical & Trials
- Unique Device Identification(UDI)Regulatory
- Urology DevicesMarket Segments
- Use ErrorClinical & Trials
- Use SpecificationQuality & Risk
- Use-Related Risk Analysis(URRA)Quality & Risk
V8 terms
- Validation Master Plan(VMP)Quality & Risk
- Valuation CapInvestment & Finance
- Value Analysis Committee(VAC)Commercialization
- Value-Based Care(VBC)Reimbursement
- Venture DebtInvestment & Finance
- Verification & Validation(V&V)Quality & Risk
- Vesting ScheduleInvestment & Finance
- Vulnerability Exploitability eXchange(VEX)Cybersecurity
W6 terms