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Why this term here: The current US quality-system rule (21 CFR 820). Focus on the sections that map cleanly to ISO 13485 and the ones that do not. ](/terms/qsr?from=qms-foundations)Mark done 2. 2 [ Quality & Risk ## Quality Management System Regulation(QMSR) FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference. Why this term here: The QSR replacement that harmonizes with ISO 13485. Focus on the effective date and the delta versus today's QSR. ](/terms/qmsr?from=qms-foundations)Mark done 3. 3 [ Standards ## ISO 13485 International standard for medical device quality management systems. Why this term here: The global QMS standard. Focus on clauses 4-8 and how they underpin both QMSR and MDR/IVDR expectations. ](/terms/iso-13485?from=qms-foundations)Mark done 4. 4 [ Quality & Risk ## Design Controls Structured process governing the design of medical devices. Why this term here: The heart of your QMS from a submission perspective. Focus on planning, inputs, outputs, and traceability. ](/terms/design-controls?from=qms-foundations)Mark done 5. 5 [ Quality & Risk ## Verification & Validation(V&V) Confirming design outputs meet inputs (V) and that devices meet user needs (V). Why this term here: Where design controls meet evidence. Focus on the difference and on when validation must involve real users. ](/terms/verification-validation?from=qms-foundations)Mark done 6. 6 [ Quality & Risk ## Design History File(DHF) Compilation of records describing the design history of a finished device. Why this term here: The proof that design controls happened. Focus on what belongs in the DHF versus the technical file. ](/terms/design-history-file?from=qms-foundations)Mark done 7. 7 [ Quality & Risk ## Corrective and Preventive Action(CAPA) Systematic process to investigate and resolve quality issues and prevent recurrence. Why this term here: The most-cited system in FDA inspections. Focus on root-cause rigor and effectiveness checks, not just closure. ](/terms/capa?from=qms-foundations)Mark done 8. 8 [ Quality & Risk ## Complaint Handling Process for receiving, evaluating, and responding to device complaints. Why this term here: The main input to CAPA. Focus on complaint definition, MDR decision logic, and trending. ](/terms/complaint-handling?from=qms-foundations)Mark done 9. 9 [ Quality & Risk ## FDA Form 483 Notice of inspectional observations issued at the conclusion of an FDA inspection. Why this term here: The inspector's observation form. Focus on how to write a response that actually closes findings. ](/terms/form-483?from=qms-foundations)Mark done 10. 10 [ Quality & Risk ## Warning Letter Formal FDA notification of significant violations requiring prompt corrective action. Why this term here: What escalated 483s become. Focus on reading warning letters as free training data for your own audits. ](/terms/warning-letter?from=qms-foundations)Mark done Finished the path? Test yourself with a quiz tailored to these 10 terms. [Take the QMS Foundations quiz](/quiz?path=qms-foundations) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. 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