--- title: "Quality System - MedTech Ecosystems" description: "The quality management backbone of every device manufacturer - design controls, CAPA, risk management to ISO 14971, and the move from QSR to QMSR in the…" lang: en json-ld: --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About [All ecosystems](/ecosystems) Ecosystem # Quality System The quality management backbone of every device manufacturer - design controls, CAPA, risk management to ISO 14971, and the move from QSR to QMSR in the United States. 91 terms ## Regulatory14 - [AI Act Post-Market Monitoring ](/terms/ai-act-post-market-monitoring) - [AI Act Serious Incident Reporting ](/terms/ai-act-serious-incident-reporting) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) - [Benefit-Risk Determination ](/terms/benefit-risk) - [Class III Device ](/terms/class-iii) - [De Novo Classification Request(De Novo) ](/terms/de-novo) - [Fundamental Rights Impact Assessment(FRIA) ](/terms/ai-act-fria) - [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system) - [IVDR Risk Classes A–D ](/terms/ivdr-classes) - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [Premarket Approval(PMA) ](/terms/pma) - [Provider and Deployer (EU AI Act) ](/terms/ai-act-provider-deployer) - [Summary of Safety and Clinical Performance(SSCP) ](/terms/sscp) - [Systemic Risk (GPAI) ](/terms/ai-act-systemic-risk) ## Quality & Risk36 - [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) ## Cybersecurity5 - [AAMI TIR57 ](/terms/aami-tir57) - [AAMI TIR97(TIR97) ](/terms/aami-tir97) - [IEC 80001-1 ](/terms/iec-80001) - [NIST Cybersecurity Framework(NIST CSF) ](/terms/nist-csf) - [Secure Product Development Framework(SPDF) ](/terms/spdf) ## Clinical & Trials3 - [Informed Consent ](/terms/informed-consent) - [Real-World Evidence(RWE) ](/terms/real-world-evidence) - [Risk-Based Monitoring(RBM) ](/terms/risk-based-monitoring) ## Standards22 - [ASTM F2503 ](/terms/astm-f2503) - [Essential Performance ](/terms/essential-performance) - [ICH E6(R3) Good Clinical Practice(E6(R3)) ](/terms/ich-e6-r3) - [IEC 60601-1 ](/terms/iec-60601-1) - [IEC 60601-1-2 ](/terms/iec-60601-1-2) - [IEC 60825 ](/terms/iec-60825) - [IEC 62304 ](/terms/iec-62304) - [IEC 62366-1 ](/terms/iec-62366-1) - [IEC 82304-1 ](/terms/iec-82304-1) - [ISO 10993-1 ](/terms/iso-10993-1) - [ISO 11135 ](/terms/iso-11135) - [ISO 11137 ](/terms/iso-11137) - [ISO 11607-1/-2 ](/terms/iso-11607) - [ISO 13485 ](/terms/iso-13485) - [ISO 14155 ](/terms/iso-14155) - [ISO 14971 ](/terms/iso-14971) - [ISO 15223-1 Symbols ](/terms/iso-15223-1) - [ISO 17665 ](/terms/iso-17665) - [ISO 20417 ](/terms/iso-20417) - [ISO 22301 ](/terms/iso-22301) - [ISO/IEC 23894 ](/terms/iso-iec-23894) - [ISO/TR 24971 ](/terms/tr24971) ## Software & AI2 - [EU AI Act ](/terms/eu-ai-act) - [ONC HTI-1 / HTI-2 ](/terms/onc-hti) ## Manufacturing3 - [Counterfeit Parts and Suspect Components ](/terms/counterfeit-parts) - [Process Capability (Cp/Cpk) and SPC ](/terms/spc-cpk) - [Process Capability and Cpk ](/terms/process-capability-cpk) ## Post-Market4 - [5-Day Report ](/terms/five-day-report) - [FDA Recall Classifications I, II, III ](/terms/recall-classifications) - [Field Safety Corrective Action(FSCA) ](/terms/fsca) - [Health Hazard Evaluation(HHE) ](/terms/health-hazard-eval) ## Reimbursement2 - [Joint Clinical Assessment(JCA) ](/terms/jca) - [Recovery Audit Contractor(RAC) ](/terms/rac-audit) ### Other ecosystems [Regulated Pathways](/ecosystems/regulated-pathways)[AI / ML in Devices](/ecosystems/ai-ml)[Connected & Cyber-Physical Devices](/ecosystems/connected-devices)[Software Lifecycle](/ecosystems/software-lifecycle)[Clinical Evidence](/ecosystems/clinical-evidence)[Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets)[Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer)[Startup Lifecycle](/ecosystems/startup-lifecycle)[Strategic Landscape](/ecosystems/strategic-landscape)[Manufacturing & Supply](/ecosystems/manufacturing-supply) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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