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The MedTech vocabulary, organized into the domains that regulatory, quality, clinical, software, and commercial teams work in every day.
Regulatory
FDA, EU MDR/IVDR, and global pathways for getting devices to market.
59 termsView in glossary
- 510(k) Premarket Notification(510(k))
- 513(g) Request for Information(513(g))
- Abbreviated 510(k)
- Accreditation Scheme for Conformity Assessment(ASCA)
- ANVISA(ANVISA)
- Authorized Representative (EU)(EC REP)
- Benefit-Risk Determination
- Breakthrough Device Designation(BDD)
- CE Mark
- Class III Device
- Combination Product
- Common Specifications(CS)
- De Novo Classification Request(De Novo)
- Electronic Instructions for Use(eIFU)
- eSTAR
- EU In Vitro Diagnostic Regulation(IVDR)
- EU Medical Device Regulation(MDR)
- EUDAMED
- FDA Recognized Consensus Standards
- General Controls
- General Safety and Performance Requirements(GSPRs)
- Health Canada Medical Device Licence(MDL)
- Humanitarian Device Exemption(HDE)
- IMDRF
- Importer and Distributor Obligations (EU)
- Indications for Use(IFU (statement))
- Instructions for Use(IFU)
- Intended Use
- ISO 20916
- IVDR Risk Classes A–D
- Labeling
- Letter to File(LTF)
- MDR Article 117
- Medical Device Coordination Group Guidance(MDCG)
- Medical Device User Fee Amendments(MDUFA)
- MHRA / UKCA Marking(MHRA / UKCA)
- Ministry of Food and Drug Safety (Korea)(MFDS)
- National Medical Products Administration(NMPA)
- NMPA Innovative Medical Device Pathway
- Notified Body(NB)
- Person Responsible for Regulatory Compliance(PRRC)
- Pharmaceuticals and Medical Devices Agency(PMDA)
- Predicate Device
- Premarket Approval(PMA)
- Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub)
- Refuse to Accept(RTA)
- Request for Designation(RFD)
- Safer Technologies Program(STeP)
- Saudi Food and Drug Authority(SFDA)
- Special 510(k)(Special 510(k))
- Special Controls
- Substantial Equivalence(SE)
- Summary of Safety and Clinical Performance(SSCP)
- Swissmedic
- Therapeutic Goods Administration(TGA)
- Third-Party Review of 510(k)(3P 510(k))
- UK Responsible Person(UKRP)
- Unique Device Identification(UDI)
- WHO Prequalification (Diagnostics)(WHO PQ Dx)
Quality & Risk
QMS, risk management, and process controls for medical devices.
36 termsView in glossary
- Biocompatibility
- CAPA Effectiveness Check
- Change Control
- Complaint Handling
- Corrective and Preventive Action(CAPA)
- Design Controls
- Design History File(DHF)
- Document Control
- Failure Mode and Effects Analysis(FMEA)
- Fault Tree Analysis(FTA)
- FDA Form 483
- Hazard, Hazardous Situation, and Harm
- Internal Audit
- IQ / OQ / PQ
- ISO 31000
- Management Representative
- Management Review
- Medical Device Single Audit Program(MDSAP)
- Nonconformance (NCR)(NCR)
- Post-Production Information (Risk)
- Process FMEA vs Design FMEA(PFMEA / DFMEA)
- Production and Process Controls
- Quality Management System Regulation(QMSR)
- Quality Manual
- Quality System Regulation(QSR / 21 CFR 820)
- Risk Acceptability Matrix
- Risk Management File(RMF)
- Servicing (21 CFR 820.200)
- Shelf Life
- Summative vs. Formative Evaluation
- Training Records
- Use Specification
- Use-Related Risk Analysis(URRA)
- Validation Master Plan(VMP)
- Verification & Validation(V&V)
- Warning Letter
Cybersecurity
Threat modeling, SBOMs, and secure-by-design for connected devices.
42 termsView in glossary
- AAMI SW96
- AAMI TIR57
- Brainjacking
- Common Vulnerabilities and Exposures(CVE)
- Common Vulnerability Scoring System(CVSS)
- Coordinated Vulnerability Disclosure(CVD)
- Cryptographic Agility
- CycloneDX
- De-Identification of Health Data
- Hardcoded Credentials
- HIPAA(HIPAA)
- HITECH Act(HITECH)
- HSCC Joint Security Plan(HSCC JSP)
- IEC 80001-1
- IEC 81001-5-1
- IMDRF Principles and Practices for Medical Device Cybersecurity
- ISO/IEC 27001(ISO 27001)
- Legacy Device Cybersecurity
- Manufacturer Disclosure Statement for Medical Device Security(MDS2)
- Medhacking
- Medjacking
- NIST Cybersecurity Framework(NIST CSF)
- NIST SP 800-53 / 800-171(NIST 800-53/171)
- Over-the-Air Updates(OTA)
- OWASP IoT and Embedded Application Security
- Patchability
- Penetration Testing
- PHI and ePHI
- Premarket Cybersecurity Submission
- Refuse to Accept (Cybersecurity)(RTA (cyber))
- SAST and DAST
- Section 524B of the FD&C Act(524B)
- Secure Boot
- Secure Product Development Framework(SPDF)
- Side-Channel Attack
- Software Bill of Materials(SBOM)
- Software Safety Case
- SPDX(SPDX)
- STRIDE Threat Model(STRIDE)
- Threat Modeling
- Vulnerability Exploitability eXchange(VEX)
- Zero Trust Architecture(ZTA)
Clinical & Trials
Clinical evidence, investigations, and human-factors studies.
41 termsView in glossary
- Adaptive Trial Design
- Adverse Event(AE)
- ALCOA+
- Analytical Sensitivity
- Bayesian Trial Design
- Blinding and Masking
- Case Report Form(CRF)
- Clinical Evaluation Report(CER)
- Clinical Investigation Plan(CIP)
- Composite Endpoint
- Data Safety Monitoring Board(DSMB)
- Decentralized Clinical Trial(DCT)
- Early Feasibility Study(EFS)
- Feasibility Study
- First-in-Human Study(FIH)
- Human Factors Engineering(HFE)
- ICH E6 Good Clinical Practice(GCP)
- IDE Supplement
- Informed Consent
- Institutional Review Board(IRB)
- Intent-to-Treat vs Per-Protocol(ITT / PP)
- Investigational Device Exemption(IDE)
- Investigator-Initiated Trial(IIT)
- Limit of Detection / Limit of Quantitation(LoD / LoQ)
- Lost to Follow-up
- Master Protocol (Basket / Umbrella / Platform)
- Minimal Clinically Important Difference(MCID)
- Non-Inferiority Trial
- Pivotal Trial
- Pragmatic Trial
- Primary and Secondary Endpoints
- Propensity Score Methods
- Protocol Deviation
- Real-World Evidence(RWE)
- Sample Size and Statistical Power
- Serious Adverse Event(SAE)
- Sham Control
- Source Data Verification(SDV)
- Surrogate Endpoint
- Trial Master File(TMF)
- Use Error
Standards
ISO, IEC, AAMI, and other consensus standards used by regulators.
21 termsView in glossary
Software & AI
SaMD, SiMD, AI/ML models, and software lifecycle terminology.
26 termsView in glossary
- Adversarial Robustness
- AI/ML-Enabled Medical Device
- Algorithmic Bias and Fairness
- Clinical Decision Support(CDS)
- Data Governance (AI/ML)
- EU AI Act
- Explainability and Interpretability
- Federated Learning
- Foundation Model (Healthcare)
- Generative AI in Medical Devices
- Good Machine Learning Practice(GMLP)
- Interoperability
- Locked vs. Adaptive Algorithm
- Model Card
- Model Drift Monitoring
- ONC HTI-1 / HTI-2
- Predetermined Change Control Plan(PCCP)
- Predetermined Maintenance vs PCCP
- Secure-by-Design (Devices)
- Software as a Medical Device(SaMD)
- Software in a Medical Device(SiMD)
- Software Maintenance Plan
- Software of Unknown Provenance(SOUP)
- Software Safety Classification
- Synthetic Data
- Total Product Lifecycle(TPLC)
Manufacturing
Design transfer, production controls, and supply chain terms.
22 termsView in glossary
- Bill of Materials(BOM)
- Bioburden
- Cleanroom Classes (ISO 14644)
- Container Closure Integrity(CCI)
- Counterfeit Parts and Suspect Components
- Design Transfer
- Device History Record(DHR)
- Device Master Record(DMR)
- Endotoxin Testing (LAL)
- Engineering Change Order / Notice(ECO / ECN)
- Lot Traceability
- MRP and ERP Systems(MRP / ERP)
- Pre-Approval Inspection(PAI)
- Process Capability (Cp/Cpk) and SPC
- Process Capability and Cpk
- Process Validation
- Scrap Rate and Yield
- Stability Testing
- Sterilization
- Supplier Controls
- Technology Transfer (Manufacturing)
- UDI-DI vs. UDI-PI
Post-Market
Surveillance, vigilance, recalls, and lifecycle management.
21 termsView in glossary
- 5-Day Report
- Annual Report (PMA)
- Customer Notification Letter
- Electronic Medical Device Reporting(eMDR)
- FDA Recall Classifications I, II, III
- Field Action vs Recall
- Field Safety Corrective Action(FSCA)
- Global Unique Device Identification Database(GUDID)
- Health Hazard Evaluation(HHE)
- Manufacturer Incident Report(MIR)
- Medical Device Recall
- Medical Device Reporting (FDA)(MDR)
- Medical Device Vigilance
- Periodic Safety Update Report(PSUR)
- Post-Market Clinical Follow-up(PMCF)
- Post-Market Performance Follow-up(PMPF)
- Post-Market Surveillance(PMS)
- Post-Market Surveillance Plan
- PSUR (IVDR Specific)
- Removal vs Correction (21 CFR 806)
- Trend Reporting (MDR/MIR)
Investment & Finance
Venture financing, term sheets, valuation, and capital structure for MedTech startups.
38 termsView in glossary
- 409A Valuation
- Anti-Dilution Protection
- Bridge Round
- Burn Rate
- Burn Rate and Runway
- Capitalization Table(Cap Table)
- Convertible Note
- Dilution
- Down Round
- Drag-Along and Tag-Along Rights
- Due Diligence
- Earn-Out
- Employee Option Pool
- Exit Multiple
- Initial Public Offering(IPO)
- Limited Partner / General Partner(LP / GP)
- Liquidation Preference
- Liquidity Event
- Mergers and Acquisitions(M&A)
- Milestone Payment
- Milestone-Based Tranche
- Non-Dilutive Funding
- Post-Money Valuation
- Pre-Money Valuation
- Preferred Stock
- Pro-Rata Rights
- Royalty Financing
- Runway
- SBIR / STTR Grants(SBIR/STTR)
- Series A / B / C Financing Rounds
- Simple Agreement for Future Equity(SAFE)
- Special Purpose Acquisition Company(SPAC)
- Strategic Investor
- Term Sheet
- Tranched Financing
- Valuation Cap
- Venture Debt
- Vesting Schedule
Market Segments
Therapeutic and technology segments - cardiovascular, IVD, surgical robotics, DTx, and more.
38 termsView in glossary
- Aesthetic & Energy-Based Devices
- AI Imaging Software
- Cardiac Rhythm Management(CRM)
- Cardiovascular Devices
- Clinical Laboratory Improvement Amendments(CLIA)
- Companion Diagnostic(CDx)
- Dental Devices
- Diabetes Care
- Digital Therapeutic(DTx)
- Digital Therapeutics(DTx)
- Drug Delivery Devices
- Electrophysiology(EP)
- Endoscopy Devices
- ENT Devices
- Hearing Devices
- In Vitro Diagnostics(IVD)
- In Vitro Diagnostics (Segment)(IVD)
- Laboratory-Developed Test(LDT)
- Medical Imaging
- Molecular Diagnostics
- Neuromodulation
- Ophthalmology Devices
- Orthopedic Devices
- Patient Monitoring
- Point-of-Care Diagnostics(POC)
- Remote Patient Monitoring(RPM)
- Renal Care Devices
- Respiratory Devices
- Single-Use Device(SUD)
- Sleep & Respiratory Devices
- Spine
- Structural Heart
- Surgical Robotics
- Urology Devices
- Wearable Medical Devices
- Wearables and Remote Patient Monitoring(RPM)
- Women's Health Devices
- Wound Care
Reimbursement
Coding, coverage, and payment pathways across CMS, commercial payers, and global HTAs.
36 termsView in glossary
- 340B Drug Pricing Program(340B)
- Ambulatory Payment Classification(APC)
- ASC Site-of-Service Shift
- Budget Impact Model(BIM)
- Bundled Payment
- Category III CPT Code
- Category III CPT Codes
- CMS IDE Coverage (Category A & B)
- Coverage with Evidence Development(CED)
- CPT Codes(CPT)
- Current Procedural Terminology Codes(CPT)
- Durable Medical Equipment, Prosthetics, Orthotics, and Supplies(DMEPOS)
- HCPCS Codes(HCPCS)
- Health Economics and Outcomes Research(HEOR)
- Health Technology Assessment(HTA)
- ICD-10-CM / ICD-10-PCS
- Incremental Cost-Effectiveness Ratio(ICER)
- Inpatient Prospective Payment System(IPPS)
- Joint Clinical Assessment(JCA)
- LCD and NCD
- Medicare Administrative Contractor(MAC)
- Medicare Physician Fee Schedule(MPFS)
- MS-DRG(MS-DRG)
- National and Local Coverage Determinations(NCD / LCD)
- New Technology Add-On Payment(NTAP)
- Outpatient Prospective Payment System(OPPS)
- Prior Authorization
- Proprietary Laboratory Analyses Codes(PLA)
- Protecting Access to Medicare Act(PAMA)
- Quality-Adjusted Life Year(QALY)
- Recovery Audit Contractor(RAC)
- RWE for Reimbursement
- Site-Neutral Payment
- Transitional Coverage for Emerging Technologies(TCET)
- Transitional Pass-Through Payment(TPT)
- Value-Based Care(VBC)
Commercialization
Go-to-market, sales channels, KOLs, and hospital purchasing dynamics.
23 termsView in glossary
- AdvaMed Code of Ethics
- Advisory Board
- Anti-Kickback Statute(AKS)
- Bottom-Up Market Sizing
- Distributor vs Direct Sales
- Field Clinical Engineer(FCE)
- Freedom to Operate(FTO)
- Good Clinical Practice(GCP)
- Group Purchasing Organization(GPO)
- Integrated Delivery Network(IDN)
- Key Opinion Leader(KOL)
- Label Claims
- Launch Readiness
- Managed Service / Reagent Rental
- Off-Label Use
- Physician Payments Sunshine Act
- Physician Training and Proctoring
- Pre-Submission Meeting(Q-Sub)
- Razor / Razor-Blade Model
- Stark Law
- Strategic Acquisition
- TAM / SAM / SOM
- Value Analysis Committee(VAC)
Industry Bodies
Vendor-neutral trade associations, standards-setting organizations, professional societies, public-private consortia, and non-commercial accelerator programs.
13 termsView in glossary
- AAMI(AAMI)
- AdvaMed
- AdvaMedDx
- Contract Research Organization(CRO)
- Corporate Venture Capital(CVC)
- Fogarty Innovation
- Industry Trade Organizations
- Medical Device Innovation Consortium(MDIC)
- MedTech Accelerators and Incubators
- MedTech Innovator
- Regulatory Affairs Professionals Society(RAPS)
- Specialty MedTech Venture Capital
- Texas Medical Center Innovation(TMC Innovation)