Medical Devices
Quality management, regulatory compliance and documentation review across the medical device lifecycle.
41 articles
- ISO 14971 Risk Management Checklist: What FDA Inspectors Look for in 2026 Risk management is FDA's top QMSR inspection finding. Use this clause-by-clause ISO 14971 checklist to close the gaps inspectors cite.
- Medical Device Manufacturing in 2026: Regulations, Tariffs and Automation QMSR is in force, tariffs are reshaping supply chains and automation is rising. What US medical device manufacturers need to know in 2026.
- Medical Device Compliance in 2026: An FDA and EU Regulatory Compliance Guide QMSR, new inspection rules, higher user fees and EU MDR reform: a practical 2026 guide to medical device regulatory compliance across the lifecycle.
- Medical Device Regulations Explained: FDA Classes, Pathways and 2026 Updates How US medical device regulations work in 2026: device classes, 510(k), De Novo and PMA, the key 21 CFR parts, FY2027 fees and EU MDR updates.
- Medical Device Automation: Validating Automated Manufacturing and QA Under QMSR Automating medical device production or QA? How QMSR and FDA's 2026 CSA guidance shape validation, plus a step-by-step automation roadmap.
- Medical Device Compliance Software: A 2026 Buyer's Guide to Quality Management Tools eQMS, RIM, PLM or AI document review? How to choose medical device compliance and quality management software that fits QMSR and FDA's CSA guidance.
- Medical Device Certification Explained: FDA Clearance, CE Marking and ISO 13485 FDA doesn't certify devices. Learn what FDA clearance, CE marking, ISO 13485 and MDSAP certification really mean, and which ones you need in 2026.
- Medical Device Audits in 2026: Internal, Supplier, Notified Body and MDSAP Internal, supplier, notified body and MDSAP audits explained, plus what QMSR and ISO 19011:2026 change for medical device audit programs.
- FDA Medical Device Inspections in 2026: What to Expect Under QMSR How FDA inspects device makers under QMSR and CP 7382.850: inspection types, the six QMS areas, 483s, remote assessments and a readiness checklist.
- Medical Device QMS: How to Build a Quality Management System for QMSR and ISO 13485 What a medical device QMS must contain under QMSR and ISO 13485, the FDA-specific additions, and a step-by-step plan to build or update yours in 2026.
- Medical Device Risk Management in 2026: Beyond the ISO 14971 File Risk management is the top QMSR inspection finding. How to connect ISO 14971, QMS, cybersecurity, AI and supplier risk across the device lifecycle.
- Medical Device AI in 2026: FDA Rules, the EU AI Act and What Comes Next FDA's AI device list, PCCPs, draft lifecycle guidance, LLM tagging and the EU AI Act's 2028 deadline: what medical device AI makers need to know now.
- Medical Device Quality Assurance: Roles, Processes and KPIs for 2026 What medical device quality assurance covers under QMSR, how it differs from QC, the processes QA owns and the KPIs that show your QA program works.
- Medical Device Quality System: From the QS Regulation to QMSR FDA's Quality System Regulation became the QMSR on Feb 2, 2026. What changed, what stayed, how DHF, DMR and DHR map to ISO 13485, and how to finish the switch.
- Medical Device Documentation and Documentation Review: A 2026 Guide What documentation FDA and the EU MDR require for medical devices in 2026, and a practical method and checklist for reviewing it before auditors do.
- Medical Device Assessment: Conformity Assessment in the US and EU (2026) How medical devices are assessed in 2026: EU MDR conformity routes, FDA premarket review, ASCA testing, ISO 10993-1:2025 and how to get assessment-ready.
- QMSR Compliance Software: What Medical Device Makers Need After the FDA's 2026 Transition FDA's QMSR took effect Feb 2, 2026. Learn what changed, what inspectors now review, and the capabilities your QMSR compliance software needs.
- Design History File Software: How to Build an Inspection-Ready DHF Under QMSR QMSR dropped the term "DHF" but not the evidence. See what FDA inspectors check in design files in 2026 and what your DHF software must do.
- CAPA Management Software for Medical Devices: What Changed Under QMSR CAPA was FDA's top device 483 citation in FY2025. See how QMSR changed CAPA, what inspectors check in 2026, and what your CAPA software needs.
- Medical Device Complaint Handling: FDA Requirements, MDR Reportability and a 2026 Checklist Complaint handling is a top-3 FDA finding under QMSR. Learn the § 820.35 record rules, MDR 30-day and 5-day timelines, and use this 2026 checklist.
- Medical Device Supplier Qualification and Audit Checklist Under QMSR Outsourcing and purchasing is FDA's #2 QMSR finding. Use this supplier qualification, audit and quality agreement checklist built for 2026 inspections.
- Medical Device Change Impact Assessment: When Do You Need a New 510(k)? Not evaluating changes is a possible OAI finding under QMSR. Learn how to assess device changes, decide on a new 510(k) and use PCCPs in 2026.
- Medical Device Post-Market Surveillance Checklist: FDA and EU MDR in 2026 One PMS checklist for FDA (Parts 803, 806, 822, 821) and EU MDR (Articles 83–86), with 2026 changes: AEMS, MDCG 2025-10 and the PSUR reform proposal.
- Medical Device Regulatory Affairs in 2026: Role, Responsibilities and Trends What medical device regulatory affairs teams do, the skills they need, and the 2026 trends reshaping the role: eSTAR, FDA's AI tools, MDUFA VI and EUDAMED.
- Medical Device Regulatory Software: RIM, Submissions and Regulatory Intelligence Tools RIM, submission, regulatory intelligence and AI assessment tools for medical device RA teams: what they do, what changed in 2026 and how to choose.
- ISO 13485 in 2026: Requirements, QMSR Alignment and Compliance Guide ISO 13485:2016 was reconfirmed in 2025 and is now part of FDA's QMSR. What the standard requires, how certification works and how to stay compliant.
- EU MDR in 2026: Deadlines, the Simplification Proposal and a Compliance Roadmap EU MDR status in 2026: transition deadlines, mandatory EUDAMED, the Commission's simplification proposal and a compliance roadmap for US device makers.
- FDA Compliance in 2026: Regulatory Requirements, Enforcement Trends and Compliance Software What FDA compliance requires by product type, the 2025-2026 enforcement trends, how to build a compliance program, and what FDA compliance software should do.
- CE Marking for Medical Devices: A Step-by-Step Guide for US Manufacturers (2026) How US manufacturers CE mark medical devices under the EU MDR in 2026: classification, conformity routes, notified bodies, technical documentation and EUDAMED.
- Medical Device Regulatory Assessment: How to Determine Classification, Pathway and Readiness for the US and EU How to run a medical device regulatory assessment: FDA classification and 510(k), De Novo or PMA, EU MDR class and conformity route, and readiness for 2026 rules.
- Post-Market Surveillance for Medical Devices: FDA and EU MDR Requirements in 2026 What post-market surveillance requires under FDA rules and the EU MDR in 2026: MDR reporting, 522 studies, recalls, PMS plans, PSURs, AEMS and EUDAMED.
- Medical Device Vigilance Under the EU MDR: Serious Incidents, Trend Reports and FSCAs in 2026 EU MDR vigilance for device makers: 2, 10 and 15-day serious incident deadlines, trend reporting, FSCAs, the new MIR form and EUDAMED status in 2026.
- Medical Device Complaint Investigation, Assessment and Trending: A Practical Guide for 2026 How device makers should assess, investigate and trend complaints under the QMSR and ISO 13485, what FDA warning letters reveal, and a practical checklist.
- Design History File (DHF) Under the QMSR: What It Is, What Changed and How to Review It What a design history file is, what changed when the QMSR replaced it with ISO 13485's design and development file, and how to review and audit one.
- Requirements Traceability for Medical Devices: Building a Traceability Matrix Auditors Trust Build requirements traceability that FDA and auditors trust: what ISO 13485, FDA software guidance and IEC 62304 expect, matrix structure and AI checks.
- Design Verification for Medical Devices: Requirements, Methods and Common FDA Findings What design verification requires under the QMSR and ISO 13485, how to plan tests and justify sample sizes, and the verification gaps FDA cites.
- Medical Device Design Control in 2026: Requirements After the QMSR and How to Stay Compliant Design control after the QMSR: what ISO 13485 clause 7.3 requires, how FDA inspects design, risk links, agile development and a compliance checklist.
- Design Validation for Medical Devices: User Needs, Human Factors and Clinical Evidence Design validation under the QMSR and ISO 13485: FDA's May 2026 human factors guidance, clinical and software evidence, and common FDA findings.
- Process Validation: The Three Stages, What FDA and EU Expect, and Common Gaps What process validation means under FDA's lifecycle guidance and EU Annex 15, what each stage requires, and the gaps FDA cited in 2026 warning letters.
- Regulatory Affairs in Life Sciences: What the Function Does and How It Is Changing What regulatory affairs does in pharma and medical devices, its core lifecycle responsibilities, and how eCTD 4.0, eSTAR, EU reform and AI are changing it.
- Supplier Quality Management: Requirements, Process and Software The supplier quality management lifecycle in pharma and devices: 21 CFR 211, ICH Q10, EU GMP and ISO 13485 requirements, FDA citations and SQM software.
Subjects covered
- medical device compliance
- medical device regulations
- medical device quality management
- medical device QMS
- medical device regulatory affairs
- medical device manufacturing
- medical device documentation
- medical device audit
- medical device inspection
- medical device risk management
- medical device quality assurance
- medical device regulatory compliance