Quality Systems
191 articles
Medical Device CMO Selection and Quality Agreement Guide
How to select a medical device CMO, define quality agreements, run supplier audits, manage change control, and align outsourced manufacturing with FDA QMSR and ISO 13485.
Design Output Documentation for Medical Devices: Drawings, Specs, BOMs
Guide to medical device design output records, including drawings, specifications, BOMs, acceptance criteria, and traceability to design inputs under FDA QMSR and ISO 13485.
Design Review Evidence for Medical Devices: Agenda, Minutes, Independence
Guide to medical device design review records, covering agenda planning, meeting minutes, independent reviewers, FDA and ISO expectations, and audit-ready evidence.
Design Transfer to Manufacturing: DMR, Validation, and Supplier Handoff
Guide to medical device design transfer, including DMR readiness, IQ/OQ/PQ process validation, supplier qualification, production handoff, and audit-ready documentation.
EDC Validation for Medical Device Trials: Part 11 and Data Integrity
Guide to validating EDC systems for medical device clinical trials, covering 21 CFR Part 11, audit trails, GAMP 5, IQ/OQ/PQ, ALCOA+ data integrity, sponsor duties, and FDA inspection risks.
Hazard Analysis Methods for Medical Devices: FMEA, FTA, PHA, HAZOP
Compare hazard analysis methods for device risk management, including FMEA, FTA, PHA, HAZOP, and use-related analysis under ISO 14971, IEC 62366, FDA, and EU MDR.
ISO 27001 for Medical Device Companies: Information Security Implementation Guide
Learn how medical device companies can implement ISO 27001, align ISMS controls with ISO 13485 and FDA cybersecurity expectations, and plan certification.
ISO/TR 24971 for Medical Devices: Practical Guidance for Applying ISO 14971
Practical guide to ISO/TR 24971:2020 for applying ISO 14971, including hazard identification, risk analysis methods, benefit-risk decisions, and cybersecurity.
Risk Management File vs Risk Management Report: ISO 14971 Documentation Explained
Clear guide to ISO 14971 risk management files and reports, including required contents, traceability expectations, document structure, and audit findings.
User Needs vs Design Inputs: Translating VOC into Medical Device Requirements
Learn how to translate VOC and user needs into verifiable design inputs with FDA QMSR, ISO 13485, traceability examples and audit-ready documentation.
Generative AI in Medical Device Regulatory Operations
Use generative AI in device regulatory work with governance for submissions, literature review, intelligence, clinical evaluation, GxP controls, and compliance risks.
SOUP IEC 62304 Compliance Guide for Medical Device Manufacturers
Guide to managing SOUP under IEC 62304, covering identification, risk assessment, safety classification, documentation, open-source controls, and post-market monitoring.
Medical Device Acronyms & Glossary: 100+ Essential Terms Every Professional Must Know
Medical device glossary with 100+ FDA, EU MDR, quality system, clinical evidence, standards, cybersecurity, and regulatory acronyms explained for professionals.
IEC 62133 Battery Safety for Medical Devices: Testing and Compliance
Meet IEC 62133 battery safety requirements for medical devices, including testing, FDA and EU MDR expectations, UN 38.3 transport, battery management, and risk controls.
HIPAA Compliance for Medical Device Companies (2026 Security Rule Update)
Manage HIPAA compliance for connected device companies, including applicability, 2026 Security Rule proposals, encryption, MFA, BAAs, IoMT risks, and FDA cybersecurity overlap.
Endotoxin and Pyrogen Testing for Medical Devices: BET Guide
Guide to medical device endotoxin and pyrogen testing, including BET methods, rFC alternatives, ISO 11737-3, USP <85>/<161>, FDA guidance, and device limits.
Switzerland Swissmedic Medical Device Registration Guide (2026)
How to register medical devices in Switzerland under Swissmedic: CH-REP duties, MedDO/IvDO rules, swissdamed deadlines, CE reliance, fees, and PMS obligations.
Batch Records for Medical Devices: BMR, EBR, DHR, and FDA QMSR
Guide to batch manufacturing records, electronic batch records, and DHRs for medical devices, covering 21 CFR 210/211, FDA QMSR, ISO 13485, review workflows, deviations, and inspection readiness.
Bioburden Testing for Medical Devices: Complete ISO 11737-1 Guide
Guide to bioburden testing under ISO 11737-1:2018, covering method validation, recovery efficiency, extraction, enumeration, dose setting, and routine monitoring for medical device sterilization.
Cleanroom Standards for Medical Devices: Complete ISO 14644 Guide
Classify, design, validate, and monitor ISO 14644 cleanrooms for medical devices, including particle limits, environmental monitoring, FDA/EU GMP expectations, and 2025 updates.