--- title: "Quality & Risk Terms - MedTech Terms" description: "QMS, risk management, and process controls for medical devices. 36 vendor-neutral definitions with primary-source citations." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTermSet", "@id": "https://medtechterms.com/categories/quality-and-risk#set", "name": "Quality & Risk - MedTech Terms", "description": "QMS, risk management, and process controls for medical devices.", "url": "https://medtechterms.com/categories/quality-and-risk", "hasDefinedTerm": [ { "@type": "DefinedTerm", "name": "Biocompatibility", "url": "https://medtechterms.com/terms/biocompatibility", "termCode": "biocompatibility" }, { "@type": "DefinedTerm", "name": "CAPA Effectiveness Check", "url": "https://medtechterms.com/terms/capa-effectiveness", "termCode": "capa-effectiveness" }, { "@type": "DefinedTerm", "name": "Change Control", "url": "https://medtechterms.com/terms/change-control", "termCode": 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process to investigate and resolve quality issues and prevent recurrence. ](/terms/capa)[ Design Controls Structured process governing the design of medical devices. ](/terms/design-controls)[ Medical Device Single Audit Program(MDSAP) Single audit of a manufacturer's QMS satisfying multiple participating regulators. ](/terms/mdsap)[ Quality Management System Regulation(QMSR) FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference. ](/terms/qmsr)[ Quality System Regulation(QSR / 21 CFR 820) FDA's current good manufacturing practice (cGMP) requirements for medical devices. ](/terms/qsr)[ Risk Management File(RMF) Set of records and outputs from the ISO 14971 risk management process. ](/terms/risk-management-file) ## All Quality & Risk terms - [Biocompatibility ](/terms/biocompatibility) - [CAPA Effectiveness Check ](/terms/capa-effectiveness) - [Change Control ](/terms/change-control) - [Complaint Handling ](/terms/complaint-handling) - [Corrective and Preventive Action(CAPA) ](/terms/capa) - [Design Controls ](/terms/design-controls) - [Design History File(DHF) ](/terms/design-history-file) - [Document Control ](/terms/document-control) - [Failure Mode and Effects Analysis(FMEA) ](/terms/fmea) - [Fault Tree Analysis(FTA) ](/terms/fta) - [FDA Form 483 ](/terms/form-483) - [Hazard, Hazardous Situation, and Harm ](/terms/hazard-vs-harm) - [Internal Audit ](/terms/internal-audit) - [IQ / OQ / PQ ](/terms/iq-oq-pq) - [ISO 31000 ](/terms/iso-31000) - [Management Representative ](/terms/management-representative) - [Management Review ](/terms/management-review) - [Medical Device Single Audit Program(MDSAP) ](/terms/mdsap) - [Nonconformance (NCR)(NCR) ](/terms/nonconformance) - [Post-Production Information (Risk) ](/terms/post-production-info) - [Process FMEA vs Design FMEA(PFMEA / DFMEA) ](/terms/pfmea-vs-dfmea) - [Production and Process Controls ](/terms/production-process-controls) - [Quality Management System Regulation(QMSR) ](/terms/qmsr) - [Quality Manual ](/terms/quality-manual) - [Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) - [Risk Acceptability Matrix ](/terms/risk-acceptability-matrix) - [Risk Management File(RMF) ](/terms/risk-management-file) - [Servicing (21 CFR 820.200) ](/terms/servicing) - [Shelf Life ](/terms/shelf-life) - [Summative vs. Formative Evaluation ](/terms/summative-formative) - [Training Records ](/terms/training-records) - [Use Specification ](/terms/use-specification) - [Use-Related Risk Analysis(URRA) ](/terms/urra) - [Validation Master Plan(VMP) ](/terms/validation-master-plan) - [Verification & Validation(V&V) ](/terms/verification-validation) - [Warning Letter ](/terms/warning-letter) ## Explore related categories [Regulatory](/categories/regulatory)[Cybersecurity](/categories/cybersecurity)[Clinical & Trials](/categories/clinical-and-trials)[Standards](/categories/standards)[Software & AI](/categories/software-and-ai)[Manufacturing](/categories/manufacturing)[Post-Market](/categories/post-market)[Investment & Finance](/categories/investment-and-finance)[Market Segments](/categories/market-segments)[Reimbursement](/categories/reimbursement)[Commercialization](/categories/commercialization)[Industry Bodies](/categories/industry-bodies) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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