Updated daily
Changelog
Every review, revision, and new term - dated. We track sources across FDA, EU MDR/IVDR, ISO, IEC, IMDRF, and other primary authorities, and stamp each entry when we last verified it.
Review status Primary-sourcedreviewed against binding law or regulator guidance Supportingreviewed against research or industry sources
Monthly review cycle
Once a month the terms flagged here are pulled forward: every citation on them is re-checked, and the review date is only restamped when the sources still resolve. Fast-moving categories (Cybersecurity, Regulatory, Software and AI, Standards, Quality and Risk, Post-Market) are flagged after 120 days, the rest after 240 days.
33
flagged for review
335
expanded definitions source-checked last pass (October 9, 2026)
0
held back for a source fix
Next in the queue
- CISA Known Exploited Vulnerabilities Catalogdue October 18, 2026
- MITRE ATT&CKdue October 18, 2026
- MITRE D3FENDdue October 18, 2026
- Common Weakness Enumerationdue October 18, 2026
- Health Industry Cybersecurity Practicesdue October 18, 2026
- Healthcare and Public Health Cybersecurity Performance Goalsdue October 18, 2026
- Health Information Sharing and Analysis Centerdue October 18, 2026
- AAMI TIR97due October 18, 2026
- Secure Software Development Frameworkdue October 18, 2026
- Supply-chain Levels for Software Artifactsdue October 18, 2026
- Code Signingdue October 18, 2026
- Hardware Root of Trustdue October 18, 2026
21 more terms queued behind these.
September 19, 2026
228 terms reviewed- 510(k) Premarket Notification(510(k))Primary-sourced3 srcRegulatory
- Premarket Approval(PMA)Primary-sourced3 srcRegulatory
- De Novo Classification Request(De Novo)Primary-sourced3 srcRegulatory
- Substantial Equivalence(SE)Primary-sourced3 srcRegulatory
- Predicate DevicePrimary-sourced3 srcRegulatory
- Quality System Regulation(QSR / 21 CFR 820)Primary-sourced3 srcQuality & Risk
- Quality Management System Regulation(QMSR)Primary-sourced3 srcQuality & Risk
- ISO 13485Primary-sourced3 srcStandards
- ISO 14971Primary-sourced3 srcStandards
- ISO/TR 24971Primary-sourced3 srcStandards
- IEC 62304Primary-sourced3 srcStandards
- Software Safety ClassificationPrimary-sourced3 srcSoftware & AI
- IEC 62366-1Primary-sourced3 srcStandards
- IEC 60601-1Primary-sourced3 srcStandards
- Essential PerformancePrimary-sourced3 srcStandards
- IEC 60601-1-2Primary-sourced3 srcStandards
- ISO 10993-1Primary-sourced3 srcStandards
- BiocompatibilityPrimary-sourced3 srcQuality & Risk
- Software as a Medical Device(SaMD)Primary-sourced3 srcSoftware & AI
- Software in a Medical Device(SiMD)Primary-sourced3 srcSoftware & AI
- Clinical Decision Support(CDS)Primary-sourced3 srcSoftware & AI
- Refuse to Accept(RTA)Primary-sourced3 srcRegulatory
- Unique Device Identification(UDI)Primary-sourced3 srcRegulatory
- EU Medical Device Regulation(MDR)Primary-sourced3 srcRegulatory
- EU In Vitro Diagnostic Regulation(IVDR)Primary-sourced3 srcRegulatory
- Notified Body(NB)Primary-sourced3 srcRegulatory
- CE MarkPrimary-sourced3 srcRegulatory
- EUDAMEDPrimary-sourced3 srcRegulatory
- Corrective and Preventive Action(CAPA)Primary-sourced3 srcQuality & Risk
- Nonconformance (NCR)(NCR)Primary-sourced3 srcQuality & Risk
- Complaint HandlingPrimary-sourced3 srcQuality & Risk
- Design ControlsPrimary-sourced3 srcQuality & Risk
- Verification & Validation(V&V)Primary-sourced3 srcQuality & Risk
- Design History File(DHF)Primary-sourced3 srcQuality & Risk
- Risk Management File(RMF)Primary-sourced3 srcQuality & Risk
- Benefit-Risk DeterminationPrimary-sourced3 srcRegulatory
- Post-Market Surveillance(PMS)Primary-sourced3 srcPost-Market
- Periodic Safety Update Report(PSUR)Primary-sourced3 srcPost-Market
- Medical Device VigilancePrimary-sourced3 srcPost-Market
- Field Safety Corrective Action(FSCA)Primary-sourced3 srcPost-Market
- Medical Device RecallPrimary-sourced3 srcPost-Market
- Medical Device Reporting (FDA)(MDR)Primary-sourced3 srcPost-Market
- Predetermined Change Control Plan(PCCP)Primary-sourced3 srcSoftware & AI
- Good Machine Learning Practice(GMLP)Primary-sourced3 srcSoftware & AI
- Software of Unknown Provenance(SOUP)Primary-sourced3 srcSoftware & AI
- Instructions for Use(IFU)Primary-sourced3 srcRegulatory
- LabelingPrimary-sourced3 srcRegulatory
- ISO 14155Primary-sourced3 srcStandards
- Class III DevicePrimary-sourced3 srcRegulatory
- FDA Form 483Primary-sourced3 srcQuality & Risk
- Warning LetterPrimary-sourced3 srcQuality & Risk
- Intended UsePrimary-sourced3 srcRegulatory
- Indications for Use(IFU (statement))Primary-sourced3 srcRegulatory
- InteroperabilityPrimary-sourced3 srcSoftware & AI
- IMDRFPrimary-sourced3 srcRegulatory
- Medical Device Single Audit Program(MDSAP)Primary-sourced3 srcQuality & Risk
- Shelf LifePrimary-sourced3 srcQuality & Risk
- Humanitarian Device Exemption(HDE)Primary-sourced3 srcRegulatory
- Breakthrough Device Designation(BDD)Primary-sourced3 srcRegulatory
- Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub)Primary-sourced3 srcRegulatory
- Safer Technologies Program(STeP)Primary-sourced3 srcRegulatory
- Special 510(k)(Special 510(k))Primary-sourced3 srcRegulatory
- Abbreviated 510(k)Primary-sourced3 srcRegulatory
- Combination ProductPrimary-sourced3 srcRegulatory
- Request for Designation(RFD)Primary-sourced3 srcRegulatory
- eSTARPrimary-sourced3 srcRegulatory
- Letter to File(LTF)Primary-sourced3 srcRegulatory
- Pharmaceuticals and Medical Devices Agency(PMDA)Primary-sourced3 srcRegulatory
- National Medical Products Administration(NMPA)Primary-sourced3 srcRegulatory
- Therapeutic Goods Administration(TGA)Primary-sourced3 srcRegulatory
- Health Canada Medical Device Licence(MDL)Primary-sourced3 srcRegulatory
- ANVISA(ANVISA)Primary-sourced3 srcRegulatory
- MHRA / UKCA Marking(MHRA / UKCA)Primary-sourced3 srcRegulatory
- Ministry of Food and Drug Safety (Korea)(MFDS)Primary-sourced3 srcRegulatory
- WHO Prequalification (Diagnostics)(WHO PQ Dx)Primary-sourced3 srcRegulatory
- Post-Market Clinical Follow-up(PMCF)Primary-sourced3 srcPost-Market
- Summary of Safety and Clinical Performance(SSCP)Primary-sourced3 srcRegulatory
- CAPA Effectiveness CheckPrimary-sourced3 srcQuality & Risk
- Management ReviewPrimary-sourced3 srcQuality & Risk
- Internal AuditPrimary-sourced3 srcQuality & Risk
- Document ControlPrimary-sourced3 srcQuality & Risk
- Training RecordsPrimary-sourced3 srcQuality & Risk
- Hazard, Hazardous Situation, and HarmPrimary-sourced3 srcQuality & Risk
- Failure Mode and Effects Analysis(FMEA)Primary-sourced3 srcQuality & Risk
- Fault Tree Analysis(FTA)Primary-sourced3 srcQuality & Risk
- AI/ML-Enabled Medical DevicePrimary-sourced3 srcSoftware & AI
- Locked vs. Adaptive AlgorithmPrimary-sourced3 srcSoftware & AI
- Model CardPrimary-sourced3 srcSoftware & AI
- Algorithmic Bias and FairnessPrimary-sourced3 srcSoftware & AI
- Total Product Lifecycle(TPLC)Primary-sourced3 srcSoftware & AI
- EU AI ActPrimary-sourced3 srcSoftware & AI
- ISO/IEC 23894Primary-sourced3 srcStandards
- IVDR Risk Classes A–DPrimary-sourced3 srcRegulatory
- Common Specifications(CS)Primary-sourced3 srcRegulatory
- Global Unique Device Identification Database(GUDID)Primary-sourced3 srcPost-Market
- Change ControlPrimary-sourced3 srcQuality & Risk
- FDA Recall Classifications I, II, IIIPrimary-sourced3 srcPost-Market
- ISO 15223-1 SymbolsPrimary-sourced3 srcStandards
- Electronic Instructions for Use(eIFU)Primary-sourced3 srcRegulatory
- Use SpecificationPrimary-sourced3 srcQuality & Risk
- Use-Related Risk Analysis(URRA)Primary-sourced3 srcQuality & Risk
- Summative vs. Formative EvaluationPrimary-sourced3 srcQuality & Risk
- 513(g) Request for Information(513(g))Primary-sourced3 srcRegulatory
- General ControlsPrimary-sourced3 srcRegulatory
- Special ControlsPrimary-sourced3 srcRegulatory
- FDA Recognized Consensus StandardsPrimary-sourced3 srcRegulatory
- Accreditation Scheme for Conformity Assessment(ASCA)Primary-sourced3 srcRegulatory
- Third-Party Review of 510(k)(3P 510(k))Primary-sourced3 srcRegulatory
- Medical Device User Fee Amendments(MDUFA)Primary-sourced3 srcRegulatory
- MDR Article 117Primary-sourced3 srcRegulatory
- General Safety and Performance Requirements(GSPRs)Primary-sourced3 srcRegulatory
- Person Responsible for Regulatory Compliance(PRRC)Primary-sourced3 srcRegulatory
- Authorized Representative (EU)(EC REP)Primary-sourced3 srcRegulatory
- UK Responsible Person(UKRP)Primary-sourced3 srcRegulatory
- Importer and Distributor Obligations (EU)Primary-sourced3 srcRegulatory
- SwissmedicPrimary-sourced3 srcRegulatory
- Medical Device Coordination Group Guidance(MDCG)Primary-sourced3 srcRegulatory
- NMPA Innovative Medical Device PathwayPrimary-sourced3 srcRegulatory
- Saudi Food and Drug Authority(SFDA)Primary-sourced3 srcRegulatory
- ISO 20916Primary-sourced3 srcRegulatory
- Risk Acceptability MatrixPrimary-sourced3 srcQuality & Risk
- Post-Production Information (Risk)Primary-sourced3 srcQuality & Risk
- Process FMEA vs Design FMEA(PFMEA / DFMEA)Primary-sourced3 srcQuality & Risk
- ISO 31000Primary-sourced3 srcQuality & Risk
- Production and Process ControlsPrimary-sourced3 srcQuality & Risk
- Servicing (21 CFR 820.200)Primary-sourced3 srcQuality & Risk
- Validation Master Plan(VMP)Primary-sourced3 srcQuality & Risk
- IQ / OQ / PQPrimary-sourced3 srcQuality & Risk
- Management RepresentativePrimary-sourced3 srcQuality & Risk
- Quality ManualPrimary-sourced3 srcQuality & Risk
- Model Drift MonitoringPrimary-sourced3 srcSoftware & AI
- Federated LearningPrimary-sourced3 srcSoftware & AI
- Foundation Model (Healthcare)Primary-sourced3 srcSoftware & AI
- Explainability and InterpretabilityPrimary-sourced3 srcSoftware & AI
- Generative AI in Medical DevicesPrimary-sourced3 srcSoftware & AI
- Data Governance (AI/ML)Primary-sourced3 srcSoftware & AI
- Synthetic DataPrimary-sourced3 srcSoftware & AI
- Adversarial RobustnessPrimary-sourced3 srcSoftware & AI
- ONC HTI-1 / HTI-2Primary-sourced3 srcSoftware & AI
- Software Maintenance PlanPrimary-sourced3 srcSoftware & AI
- Predetermined Maintenance vs PCCPPrimary-sourced3 srcSoftware & AI
- Secure-by-Design (Devices)Primary-sourced3 srcSoftware & AI
- ISO 11607-1/-2Primary-sourced3 srcStandards
- ISO 11135Primary-sourced3 srcStandards
- ISO 11137Primary-sourced3 srcStandards
- ISO 17665Primary-sourced3 srcStandards
- ISO 20417Primary-sourced3 srcStandards
- ISO 22301Primary-sourced3 srcStandards
- IEC 60825Primary-sourced3 srcStandards
- IEC 82304-1Primary-sourced3 srcStandards
- ASTM F2503Primary-sourced3 srcStandards
- Trend Reporting (MDR/MIR)Primary-sourced3 srcPost-Market
- 5-Day ReportPrimary-sourced3 srcPost-Market
- Manufacturer Incident Report(MIR)Primary-sourced3 srcPost-Market
- Field Action vs RecallPrimary-sourced3 srcPost-Market
- Removal vs Correction (21 CFR 806)Primary-sourced3 srcPost-Market
- Customer Notification LetterPrimary-sourced3 srcPost-Market
- Health Hazard Evaluation(HHE)Primary-sourced3 srcPost-Market
- Annual Report (PMA)Primary-sourced3 srcPost-Market
- Electronic Medical Device Reporting(eMDR)Primary-sourced3 srcPost-Market
- PSUR (IVDR Specific)Primary-sourced3 srcPost-Market
- Post-Market Surveillance PlanPrimary-sourced3 srcPost-Market
- Software Bill of Materials(SBOM)Primary-sourced5 srcCybersecurity
- Section 524B of the FD&C Act(524B)Primary-sourced3 srcCybersecurity
- Premarket Cybersecurity SubmissionPrimary-sourced3 srcCybersecurity
- Secure Product Development Framework(SPDF)Primary-sourced3 srcCybersecurity
- Threat ModelingPrimary-sourced3 srcCybersecurity
- STRIDE Threat Model(STRIDE)Primary-sourced3 srcCybersecurity
- Common Vulnerabilities and Exposures(CVE)Primary-sourced3 srcCybersecurity
- Common Vulnerability Scoring System(CVSS)Primary-sourced3 srcCybersecurity
- Vulnerability Exploitability eXchange(VEX)Primary-sourced3 srcCybersecurity
- SPDX(SPDX)Primary-sourced3 srcCybersecurity
- CycloneDXPrimary-sourced3 srcCybersecurity
- Coordinated Vulnerability Disclosure(CVD)Primary-sourced4 srcCybersecurity
- PatchabilityPrimary-sourced3 srcCybersecurity
- Over-the-Air Updates(OTA)Primary-sourced3 srcCybersecurity
- Secure BootPrimary-sourced3 srcCybersecurity
- Side-Channel AttackPrimary-sourced3 srcCybersecurity
- Hardcoded CredentialsPrimary-sourced3 srcCybersecurity
- Penetration TestingPrimary-sourced3 srcCybersecurity
- SAST and DASTPrimary-sourced3 srcCybersecurity
- Refuse to Accept (Cybersecurity)(RTA (cyber))Primary-sourced3 srcCybersecurity
- IMDRF Principles and Practices for Medical Device CybersecurityPrimary-sourced3 srcCybersecurity
- Legacy Device CybersecurityPrimary-sourced3 srcCybersecurity
- HSCC Joint Security Plan(HSCC JSP)Primary-sourced3 srcCybersecurity
- IEC 80001-1Primary-sourced3 srcCybersecurity
- IEC 81001-5-1Primary-sourced3 srcCybersecurity
- AAMI TIR57Primary-sourced3 srcCybersecurity
- AAMI SW96Primary-sourced3 srcCybersecurity
- Manufacturer Disclosure Statement for Medical Device Security(MDS2)Primary-sourced3 srcCybersecurity
- OWASP IoT and Embedded Application SecurityPrimary-sourced3 srcCybersecurity
- NIST Cybersecurity Framework(NIST CSF)Primary-sourced3 srcCybersecurity
- NIST SP 800-53 / 800-171(NIST 800-53/171)Primary-sourced3 srcCybersecurity
- ISO/IEC 27001(ISO 27001)Primary-sourced3 srcCybersecurity
- HIPAA(HIPAA)Primary-sourced3 srcCybersecurity
- PHI and ePHIPrimary-sourced3 srcCybersecurity
- HITECH Act(HITECH)Primary-sourced3 srcCybersecurity
- De-Identification of Health DataPrimary-sourced3 srcCybersecurity
- Zero Trust Architecture(ZTA)Primary-sourced3 srcCybersecurity
- Cryptographic AgilityPrimary-sourced3 srcCybersecurity
- Software Safety CasePrimary-sourced3 srcCybersecurity
- BrainjackingPrimary-sourced5 srcCybersecurity
- MedjackingPrimary-sourced4 srcCybersecurity
- MedhackingPrimary-sourced6 srcCybersecurity
- Technical DocumentationPrimary-sourced3 srcRegulatory
- Harmonised StandardsPrimary-sourced3 srcStandards
- Clinical Evaluation Consultation Procedure(CECP)Primary-sourced3 srcRegulatory
- Clinical and Laboratory Standards Institute(CLSI)Primary-sourced3 srcIndustry Bodies
- ISO 17511Primary-sourced3 srcStandards
- Usability EngineeringPrimary-sourced3 srcStandards
- Quality Management System(QMS)Primary-sourced3 srcQuality & Risk
- Risk ManagementPrimary-sourced3 srcQuality & Risk
- Hazard AnalysisPrimary-sourced3 srcQuality & Risk
- Postmarket Cybersecurity ManagementPrimary-sourced3 srcCybersecurity
- Information Sharing and Analysis Organization(ISAO)Primary-sourced3 srcIndustry Bodies
- Electronic Patient-Reported Outcome(ePRO)Primary-sourced3 srcClinical & Trials
- Core LaboratoryPrimary-sourced3 srcClinical & Trials
- Pharmacogenomics(PGx)Primary-sourced3 srcClinical & Trials
- MolDx ProgramPrimary-sourced3 srcReimbursement
- Priced RoundPrimary-sourced3 srcInvestment & Finance
- Board of DirectorsPrimary-sourced3 srcInvestment & Finance
- Fully Diluted SharesPrimary-sourced3 srcInvestment & Finance
- Distribution WaterfallPrimary-sourced3 srcInvestment & Finance
- Common StockPrimary-sourced3 srcInvestment & Finance
- Protective ProvisionsPrimary-sourced3 srcInvestment & Finance
- Super Pro Rata RightsPrimary-sourced3 srcInvestment & Finance
- Pay-to-Play ProvisionPrimary-sourced3 srcInvestment & Finance
- Lock-Up PeriodPrimary-sourced3 srcInvestment & Finance
July 25, 2026
34 terms reviewed- High-Risk AI System (EU AI Act)Primary-sourced3 srcRegulatory
- General-Purpose AI Model(GPAI)Primary-sourced3 srcRegulatory
- Systemic Risk (GPAI)Primary-sourced3 srcRegulatory
- Provider and Deployer (EU AI Act)Primary-sourced3 srcRegulatory
- AI Act Conformity Assessment (Medical Devices)Primary-sourced3 srcRegulatory
- AI Act Technical Documentation (Annex IV)Primary-sourced3 srcRegulatory
- AI Act Post-Market MonitoringPrimary-sourced3 srcRegulatory
- AI Act Serious Incident ReportingPrimary-sourced3 srcRegulatory
- AI Act Transparency ObligationsPrimary-sourced3 srcRegulatory
- Fundamental Rights Impact Assessment(FRIA)Primary-sourced3 srcRegulatory
- AI Act Prohibited PracticesPrimary-sourced3 srcRegulatory
- IVDR Performance EvaluationPrimary-sourced3 srcRegulatory
- Scientific Validity (IVDR)Primary-sourced3 srcRegulatory
- Analytical Performance (IVDR)Primary-sourced3 srcRegulatory
- Clinical Performance (IVDR)Primary-sourced3 srcRegulatory
- Performance Study (IVDR)Primary-sourced3 srcClinical & Trials
- Post-Market Performance Follow-up(PMPF)Primary-sourced3 srcPost-Market
- In-House IVDs (Article 5(5))Primary-sourced3 srcRegulatory
- IVDR Legacy DevicePrimary-sourced3 srcRegulatory
- EU Reference Laboratory (EURL)(EURL)Primary-sourced3 srcRegulatory
- Self-Test and Near-Patient Testing (IVDR)Primary-sourced3 srcRegulatory
- Summary of Safety and Performance (IVDR)(SSP)Primary-sourced3 srcRegulatory
- Companion Diagnostic (IVDR)(CDx)Primary-sourced3 srcRegulatory
- Common Specifications (IVDR)(CS)Primary-sourced3 srcRegulatory
- IVDR Conformity Assessment RoutesPrimary-sourced3 srcRegulatory
- Class D Batch Verification (IVDR)Primary-sourced3 srcRegulatory
- IVDR Transitional ProvisionsPrimary-sourced3 srcRegulatory
- General Safety and Performance Requirements (IVDR)(GSPR)Primary-sourced3 srcRegulatory
- Notified Body Scrutiny (IVDR Class D)Primary-sourced3 srcRegulatory
- Genetic Testing Requirements (IVDR Article 4)Primary-sourced3 srcRegulatory
- Performance Study Application (IVDR)Primary-sourced3 srcRegulatory
- Metrological Traceability (IVDR)Primary-sourced3 srcRegulatory
- Post-Market Surveillance Plan (IVDR)Primary-sourced3 srcRegulatory
- Post-Market Performance Follow-Up (IVDR)(PMPF)Primary-sourced3 srcRegulatory
June 20, 2026
40 terms reviewed- CISA Known Exploited Vulnerabilities Catalog(KEV)Primary-sourced3 srcCybersecurity
- MITRE ATT&CK(ATT&CK)Primary-sourced3 srcCybersecurity
- MITRE D3FEND(D3FEND)Primary-sourced3 srcCybersecurity
- Common Weakness Enumeration(CWE)Primary-sourced3 srcCybersecurity
- Health Industry Cybersecurity Practices(HICP)Primary-sourced3 srcCybersecurity
- Healthcare and Public Health Cybersecurity Performance Goals(HPH-CPG)Primary-sourced3 srcCybersecurity
- Health Information Sharing and Analysis Center(H-ISAC)Primary-sourced3 srcCybersecurity
- AAMI TIR97(TIR97)Primary-sourced3 srcCybersecurity
- Secure Software Development Framework(SSDF)Primary-sourced3 srcCybersecurity
- Supply-chain Levels for Software Artifacts(SLSA)Primary-sourced3 srcCybersecurity
- Code SigningPrimary-sourced3 srcCybersecurity
- Hardware Root of Trust(HRoT)Primary-sourced3 srcCybersecurity
- LINDDUNPrimary-sourced3 srcCybersecurity
- SOC 2Primary-sourced3 srcCybersecurity
- HITRUST CSF(HITRUST)Primary-sourced3 srcCybersecurity
- FedRAMP(FedRAMP)Primary-sourced3 srcCybersecurity
- ICS Medical Advisory(ICSMA)Primary-sourced3 srcCybersecurity
- NIST IR 8473, Cybersecurity Framework Profile for HPH(NIST IR 8473)Primary-sourced3 srcCybersecurity
- Emergency Use Authorization(EUA)Primary-sourced3 srcRegulatory
- Device Master File(MAF)Primary-sourced3 srcRegulatory
- Section 522 Postmarket Surveillance(Section 522)Primary-sourced3 srcPost-Market
- 510(k) Summary vs 510(k) StatementPrimary-sourced3 srcRegulatory
- Modular PMAPrimary-sourced3 srcRegulatory
- Real-Time PMA Supplement ReviewPrimary-sourced3 srcRegulatory
- PMA Supplement TypesPrimary-sourced3 srcRegulatory
- Device Reclassification PetitionPrimary-sourced3 srcRegulatory
- Additional Condition for Nonprescription Use(ACNU)Primary-sourced3 srcRegulatory
- Real-World Data(RWD)Primary-sourced3 srcClinical & Trials
- Unanticipated Adverse Device Effect(UADE)Primary-sourced3 srcClinical & Trials
- Investigator Brochure(IB)Primary-sourced3 srcClinical & Trials
- Electronic Data Capture(EDC)Primary-sourced3 srcClinical & Trials
- Risk-Based Monitoring(RBM)Primary-sourced3 srcClinical & Trials
- ICH E6(R3) Good Clinical Practice(E6(R3))Primary-sourced3 srcStandards
- Clinical Evaluation Plan(CEP)Primary-sourced3 srcClinical & Trials
- IDE Annual Progress ReportPrimary-sourced3 srcClinical & Trials
- Medical Device Data System(MDDS)Primary-sourced3 srcSoftware & AI
- Algorithm Change Protocol(ACP)Primary-sourced3 srcSoftware & AI
- AAMI TIR45(TIR45)Primary-sourced3 srcSoftware & AI
- Datasheets for DatasetsPrimary-sourced3 srcSoftware & AI
- MLOps for Medical Devices(MLOps)Primary-sourced3 srcSoftware & AI
May 9, 2026
37 terms reviewed- Cardiac Rhythm Management(CRM)Primary-sourced3 srcMarket Segments
- Endoscopy DevicesPrimary-sourced3 srcMarket Segments
- Urology DevicesPrimary-sourced3 srcMarket Segments
- Dental DevicesPrimary-sourced3 srcMarket Segments
- Hearing DevicesPrimary-sourced3 srcMarket Segments
- Patient MonitoringPrimary-sourced3 srcMarket Segments
- Sleep & Respiratory DevicesPrimary-sourced3 srcMarket Segments
- Aesthetic & Energy-Based DevicesPrimary-sourced3 srcMarket Segments
- Single-Use Device(SUD)Primary-sourced3 srcMarket Segments
- Renal Care DevicesPrimary-sourced3 srcMarket Segments
- Ambulatory Payment Classification(APC)Primary-sourced3 srcReimbursement
- Durable Medical Equipment, Prosthetics, Orthotics, and Supplies(DMEPOS)Primary-sourced3 srcReimbursement
- Medicare Administrative Contractor(MAC)Primary-sourced3 srcReimbursement
- Proprietary Laboratory Analyses Codes(PLA)Primary-sourced3 srcReimbursement
- Site-Neutral PaymentPrimary-sourced3 srcReimbursement
- Health Economics and Outcomes Research(HEOR)Supporting3 srcReimbursement
- Budget Impact Model(BIM)Supporting3 srcReimbursement
- CMS IDE Coverage (Category A & B)Primary-sourced3 srcReimbursement
- Series A / B / C Financing RoundsPrimary-sourced3 srcInvestment & Finance
- Limited Partner / General Partner(LP / GP)Supporting3 srcInvestment & Finance
- Initial Public Offering(IPO)Primary-sourced3 srcInvestment & Finance
- Mergers and Acquisitions(M&A)Primary-sourced3 srcInvestment & Finance
- Earn-OutSupporting3 srcInvestment & Finance
- Special Purpose Acquisition Company(SPAC)Primary-sourced3 srcInvestment & Finance
- 409A ValuationPrimary-sourced3 srcInvestment & Finance
- Drag-Along and Tag-Along RightsPrimary-sourced3 srcInvestment & Finance
- Royalty FinancingPrimary-sourced3 srcInvestment & Finance
- Liquidity EventPrimary-sourced3 srcInvestment & Finance
- Non-Inferiority TrialPrimary-sourced3 srcClinical & Trials
- Sample Size and Statistical PowerPrimary-sourced3 srcClinical & Trials
- Decentralized Clinical Trial(DCT)Primary-sourced3 srcClinical & Trials
- Trial Master File(TMF)Primary-sourced3 srcClinical & Trials
- Case Report Form(CRF)Primary-sourced3 srcClinical & Trials
- Investigator-Initiated Trial(IIT)Primary-sourced3 srcClinical & Trials
- Master Protocol (Basket / Umbrella / Platform)Primary-sourced3 srcClinical & Trials
- Pragmatic TrialPrimary-sourced3 srcClinical & Trials
- Primary and Secondary EndpointsPrimary-sourced3 srcClinical & Trials
May 5, 2026
174 terms reviewed- Device Master Record(DMR)Primary-sourced3 srcManufacturing
- Device History Record(DHR)Primary-sourced3 srcManufacturing
- Design TransferPrimary-sourced3 srcManufacturing
- Process ValidationPrimary-sourced3 srcManufacturing
- Supplier ControlsPrimary-sourced3 srcManufacturing
- Human Factors Engineering(HFE)Primary-sourced3 srcClinical & Trials
- Use ErrorPrimary-sourced3 srcClinical & Trials
- Investigational Device Exemption(IDE)Primary-sourced3 srcClinical & Trials
- Institutional Review Board(IRB)Primary-sourced3 srcClinical & Trials
- Informed ConsentPrimary-sourced3 srcClinical & Trials
- ICH E6 Good Clinical Practice(GCP)Primary-sourced3 srcClinical & Trials
- Pre-Approval Inspection(PAI)Primary-sourced3 srcManufacturing
- Real-World Evidence(RWE)Primary-sourced3 srcClinical & Trials
- SterilizationPrimary-sourced3 srcManufacturing
- IDE SupplementPrimary-sourced3 srcClinical & Trials
- Clinical Evaluation Report(CER)Primary-sourced3 srcClinical & Trials
- Adverse Event(AE)Primary-sourced3 srcClinical & Trials
- Serious Adverse Event(SAE)Primary-sourced3 srcClinical & Trials
- Protocol DeviationPrimary-sourced3 srcClinical & Trials
- ALCOA+Primary-sourced3 srcClinical & Trials
- Source Data Verification(SDV)Primary-sourced3 srcClinical & Trials
- Analytical SensitivityPrimary-sourced3 srcClinical & Trials
- Limit of Detection / Limit of Quantitation(LoD / LoQ)Primary-sourced3 srcClinical & Trials
- UDI-DI vs. UDI-PIPrimary-sourced3 srcManufacturing
- Process Capability (Cp/Cpk) and SPCPrimary-sourced3 srcManufacturing
- Stability TestingPrimary-sourced3 srcManufacturing
- Current Procedural Terminology Codes(CPT)Supporting2 srcReimbursement
- Category III CPT CodesSupporting3 srcReimbursement
- ICD-10-CM / ICD-10-PCSPrimary-sourced3 srcReimbursement
- National and Local Coverage Determinations(NCD / LCD)Supporting2 srcReimbursement
- Coverage with Evidence Development(CED)Primary-sourced3 srcReimbursement
- Transitional Coverage for Emerging Technologies(TCET)Supporting2 srcReimbursement
- Value Analysis Committee(VAC)Supporting2 srcCommercialization
- AdvaMed Code of EthicsSupporting2 srcCommercialization
- Tranched FinancingSupporting3 srcInvestment & Finance
- Milestone PaymentSupporting3 srcInvestment & Finance
- Burn Rate and RunwaySupporting3 srcInvestment & Finance
- Digital Therapeutic(DTx)Supporting3 srcMarket Segments
- Cardiovascular DevicesSupporting3 srcMarket Segments
- In Vitro Diagnostics (Segment)(IVD)Supporting3 srcMarket Segments
- Wearables and Remote Patient Monitoring(RPM)Supporting3 srcMarket Segments
- Specialty MedTech Venture CapitalPrimary-sourced3 srcIndustry Bodies
- Corporate Venture Capital(CVC)Primary-sourced3 srcIndustry Bodies
- Contract Research Organization(CRO)Supporting3 srcIndustry Bodies
- MedTech Accelerators and IncubatorsSupporting3 srcIndustry Bodies
- Industry Trade OrganizationsSupporting3 srcIndustry Bodies
- Simple Agreement for Future Equity(SAFE)Primary-sourced3 srcInvestment & Finance
- Convertible NoteSupporting3 srcInvestment & Finance
- Valuation CapSupporting3 srcInvestment & Finance
- Term SheetSupporting3 srcInvestment & Finance
- Pre-Money ValuationSupporting3 srcInvestment & Finance
- Post-Money ValuationSupporting3 srcInvestment & Finance
- Capitalization Table(Cap Table)Supporting3 srcInvestment & Finance
- DilutionSupporting3 srcInvestment & Finance
- Liquidation PreferenceSupporting3 srcInvestment & Finance
- Preferred StockSupporting3 srcInvestment & Finance
- Anti-Dilution ProtectionSupporting3 srcInvestment & Finance
- Employee Option PoolSupporting3 srcInvestment & Finance
- Vesting ScheduleSupporting3 srcInvestment & Finance
- RunwaySupporting3 srcInvestment & Finance
- Burn RateSupporting3 srcInvestment & Finance
- Milestone-Based TrancheSupporting3 srcInvestment & Finance
- Pro-Rata RightsSupporting3 srcInvestment & Finance
- Down RoundSupporting3 srcInvestment & Finance
- Bridge RoundSupporting3 srcInvestment & Finance
- Strategic InvestorSupporting3 srcInvestment & Finance
- Non-Dilutive FundingSupporting3 srcInvestment & Finance
- SBIR / STTR Grants(SBIR/STTR)Primary-sourced3 srcInvestment & Finance
- Venture DebtSupporting3 srcInvestment & Finance
- Exit MultipleSupporting3 srcInvestment & Finance
- Due DiligenceSupporting3 srcInvestment & Finance
- Structural HeartSupporting3 srcMarket Segments
- Electrophysiology(EP)Supporting3 srcMarket Segments
- Orthopedic DevicesSupporting3 srcMarket Segments
- SpineSupporting3 srcMarket Segments
- Surgical RoboticsSupporting3 srcMarket Segments
- In Vitro Diagnostics(IVD)Supporting3 srcMarket Segments
- Molecular DiagnosticsSupporting3 srcMarket Segments
- Companion Diagnostic(CDx)Primary-sourced3 srcMarket Segments
- Laboratory-Developed Test(LDT)Primary-sourced3 srcMarket Segments
- Clinical Laboratory Improvement Amendments(CLIA)Primary-sourced3 srcMarket Segments
- Point-of-Care Diagnostics(POC)Supporting3 srcMarket Segments
- NeuromodulationSupporting3 srcMarket Segments
- Diabetes CareSupporting3 srcMarket Segments
- Wearable Medical DevicesPrimary-sourced3 srcMarket Segments
- Remote Patient Monitoring(RPM)Primary-sourced3 srcMarket Segments
- Digital Therapeutics(DTx)Supporting3 srcMarket Segments
- Medical ImagingSupporting3 srcMarket Segments
- AI Imaging SoftwarePrimary-sourced3 srcMarket Segments
- Ophthalmology DevicesSupporting3 srcMarket Segments
- ENT DevicesSupporting3 srcMarket Segments
- Women's Health DevicesSupporting3 srcMarket Segments
- Wound CareSupporting3 srcMarket Segments
- Respiratory DevicesSupporting3 srcMarket Segments
- Drug Delivery DevicesPrimary-sourced3 srcMarket Segments
- CPT Codes(CPT)Supporting2 srcReimbursement
- Category III CPT CodeSupporting3 srcReimbursement
- HCPCS Codes(HCPCS)Primary-sourced3 srcReimbursement
- MS-DRG(MS-DRG)Primary-sourced3 srcReimbursement
- Inpatient Prospective Payment System(IPPS)Primary-sourced3 srcReimbursement
- New Technology Add-On Payment(NTAP)Primary-sourced3 srcReimbursement
- Transitional Pass-Through Payment(TPT)Supporting2 srcReimbursement
- Outpatient Prospective Payment System(OPPS)Primary-sourced3 srcReimbursement
- ASC Site-of-Service ShiftPrimary-sourced3 srcReimbursement
- Medicare Physician Fee Schedule(MPFS)Primary-sourced3 srcReimbursement
- LCD and NCDSupporting2 srcReimbursement
- Prior AuthorizationPrimary-sourced3 srcReimbursement
- Value-Based Care(VBC)Primary-sourced3 srcReimbursement
- Bundled PaymentPrimary-sourced3 srcReimbursement
- Health Technology Assessment(HTA)Supporting3 srcReimbursement
- Joint Clinical Assessment(JCA)Primary-sourced3 srcReimbursement
- Quality-Adjusted Life Year(QALY)Supporting3 srcReimbursement
- Incremental Cost-Effectiveness Ratio(ICER)Supporting3 srcReimbursement
- RWE for ReimbursementSupporting2 srcReimbursement
- Recovery Audit Contractor(RAC)Primary-sourced3 srcReimbursement
- 340B Drug Pricing Program(340B)Primary-sourced3 srcReimbursement
- Protecting Access to Medicare Act(PAMA)Supporting2 srcReimbursement
- Key Opinion Leader(KOL)Supporting2 srcCommercialization
- Advisory BoardSupporting2 srcCommercialization
- Physician Payments Sunshine ActPrimary-sourced3 srcCommercialization
- Anti-Kickback Statute(AKS)Primary-sourced3 srcCommercialization
- Stark LawPrimary-sourced3 srcCommercialization
- Group Purchasing Organization(GPO)Supporting3 srcCommercialization
- Integrated Delivery Network(IDN)Supporting3 srcCommercialization
- Good Clinical Practice(GCP)Primary-sourced3 srcCommercialization
- Pre-Submission Meeting(Q-Sub)Primary-sourced3 srcCommercialization
- Field Clinical Engineer(FCE)Supporting2 srcCommercialization
- Razor / Razor-Blade ModelSupporting3 srcCommercialization
- Managed Service / Reagent RentalPrimary-sourced3 srcCommercialization
- TAM / SAM / SOMSupporting3 srcCommercialization
- Bottom-Up Market SizingSupporting3 srcCommercialization
- Freedom to Operate(FTO)Primary-sourced3 srcCommercialization
- Label ClaimsSupporting2 srcCommercialization
- Off-Label UseSupporting2 srcCommercialization
- Launch ReadinessSupporting3 srcCommercialization
- Physician Training and ProctoringSupporting2 srcCommercialization
- Distributor vs Direct SalesSupporting3 srcCommercialization
- Strategic AcquisitionSupporting3 srcCommercialization
- AdvaMedPrimary-sourced3 srcIndustry Bodies
- AdvaMedDxPrimary-sourced3 srcIndustry Bodies
- Medical Device Innovation Consortium(MDIC)Supporting3 srcIndustry Bodies
- Regulatory Affairs Professionals Society(RAPS)Primary-sourced3 srcIndustry Bodies
- AAMI(AAMI)Primary-sourced3 srcIndustry Bodies
- MedTech InnovatorPrimary-sourced3 srcIndustry Bodies
- Texas Medical Center Innovation(TMC Innovation)Supporting3 srcIndustry Bodies
- Fogarty InnovationPrimary-sourced3 srcIndustry Bodies
- Pivotal TrialPrimary-sourced3 srcClinical & Trials
- Feasibility StudyPrimary-sourced3 srcClinical & Trials
- Early Feasibility Study(EFS)Primary-sourced3 srcClinical & Trials
- First-in-Human Study(FIH)Primary-sourced3 srcClinical & Trials
- Sham ControlPrimary-sourced3 srcClinical & Trials
- Blinding and MaskingPrimary-sourced3 srcClinical & Trials
- Adaptive Trial DesignPrimary-sourced3 srcClinical & Trials
- Bayesian Trial DesignPrimary-sourced3 srcClinical & Trials
- Surrogate EndpointPrimary-sourced3 srcClinical & Trials
- Minimal Clinically Important Difference(MCID)Primary-sourced3 srcClinical & Trials
- Composite EndpointPrimary-sourced3 srcClinical & Trials
- Intent-to-Treat vs Per-Protocol(ITT / PP)Primary-sourced3 srcClinical & Trials
- Propensity Score MethodsPrimary-sourced3 srcClinical & Trials
- Lost to Follow-upPrimary-sourced3 srcClinical & Trials
- Data Safety Monitoring Board(DSMB)Primary-sourced3 srcClinical & Trials
- Clinical Investigation Plan(CIP)Primary-sourced3 srcClinical & Trials
- Cleanroom Classes (ISO 14644)Primary-sourced3 srcManufacturing
- BioburdenPrimary-sourced3 srcManufacturing
- Endotoxin Testing (LAL)Primary-sourced3 srcManufacturing
- Container Closure Integrity(CCI)Primary-sourced3 srcManufacturing
- Technology Transfer (Manufacturing)Primary-sourced3 srcManufacturing
- Engineering Change Order / Notice(ECO / ECN)Primary-sourced3 srcManufacturing
- Bill of Materials(BOM)Primary-sourced3 srcManufacturing
- MRP and ERP Systems(MRP / ERP)Primary-sourced3 srcManufacturing
- Lot TraceabilityPrimary-sourced3 srcManufacturing
- Scrap Rate and YieldPrimary-sourced3 srcManufacturing
- Counterfeit Parts and Suspect ComponentsPrimary-sourced3 srcManufacturing
- Process Capability and CpkPrimary-sourced3 srcManufacturing