FDA, ISO 13485 & EU MDR

Inspection readiness, FDA 483s and warning letters, QMSR, ISO 13485 audits and EU MDR technical documentation.

34 articles

Guide 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. 10 min read
Checklist FDA QMSR Checklist: An ISO 13485 Gap Analysis for U.S. Device Makers An ISO 13485 certificate won't exempt you from FDA inspection. Use this QMSR checklist to find the U.S.-specific gaps FDA inspects in 2026. 5 min read
Checklist EU MDR Technical Documentation Checklist: Annex II, Annex III and the GSPR Matrix Only 14 of 52 MDR notified bodies say most submissions are complete. Use this Annex II, Annex III and GSPR matrix checklist before you submit. 5 min read
Checklist FDA 483 Response Checklist: How to Answer Observations in 15 Business Days Respond to an FDA 483 within 15 business days and FDA reviews it before deciding on a warning letter. Use this 2026 checklist and avoid common mistakes. 4 min read
Checklist ISO 13485 Internal Audit Checklist: QMSR-Ready for 2026 FDA can now read your internal audit reports. Use this QMSR-ready ISO 13485 internal audit checklist, aligned with FDA's six inspection areas and ISO 19011:2026. 3 min read
Guide 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. 7 min read
Guide 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. 6 min read
Guide FDA Form 483 Explained: What It Means, Top Observations and How to Respond What an FDA Form 483 means, the most-cited observations for drugs and devices in FY2025, early QMSR findings, and how to write a response within 15 business days. 5 min read
Guide FDA Warning Letters in 2026: Trends, Triggers and How to Respond FDA warning letters surged in 2025 and 2026 brought the first AI and QMSR letters. What triggers a warning letter, how to respond and how to get a close-out. 6 min read
Guide FDA QMSR Explained: What Changed, What Inspectors Are Finding and What to Do Now Eight months into FDA's QMSR: how it differs from the QS regulation, how inspections changed, the top early findings and first warning letters, and what to do now. 5 min read
Guide Regulatory Compliance AI and Automation: What Works, What Regulators Expect and How to Start How AI and automation are used in regulatory compliance in 2026, what FDA and EU regulators now expect, the risks to manage and a practical framework to start. 7 min read
Guide 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. 5 min read
Guide FDA Inspections in 2026: Types, What to Expect and an Inspection Readiness Plan FDA inspections are more frequent, more unannounced and more data-driven. Inspection types, what happens on site, outcomes and a practical readiness plan. 5 min read
Guide 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. 5 min read
Checklist ISO 13485 Audit and Gap Analysis: Certification Audits, MDSAP and a Clause-by-Clause Checklist How ISO 13485 certification and MDSAP audits work, how to run a gap analysis now that FDA's QMSR cites ISO 13485, and a clause-by-clause checklist. 5 min read
Guide EU MDR Technical Documentation: Annex II and III Explained, With Common Notified Body Findings What EU MDR technical documentation must contain under Annexes II and III, the GSPR checklist, and the issues notified bodies most often cite in 2026. 5 min read
Guide 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. 5 min read
Guide Also in Medical Devices 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. 8 min read
Guide Also in Medical Devices 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. 7 min read
Guide Also in Medical Devices 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. 7 min read
Guide Also in Medical Devices 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. 7 min read
Guide Also in Medical Devices 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. 7 min read
Guide Also in Medical Devices 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. 6 min read
Guide Also in Medical Devices 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. 6 min read
Guide Also in CAPA & Complaint Management What Is CAPA? Corrective and Preventive Action Explained for 2026 CAPA explained: what corrective and preventive action means, what FDA, ICH Q10, ISO 13485 and ISO 9001 require, why CAPA tops FDA citations, and how to run it. 6 min read
Guide Also in CAPA & Complaint Management 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. 6 min read
Guide Also in CAPA & Complaint Management 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. 5 min read
Guide Also in CAPA & Complaint Management 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. 5 min read
Guide Also in Design Control, DHF & Technical Documentation 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. 6 min read
Guide Also in Design Control, DHF & Technical Documentation 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. 5 min read
Guide Also in Design Control, DHF & Technical Documentation Medical Device Technical Documentation Review: How to Review a Technical File Before FDA or a Notified Body Does How to review medical device technical documentation before an FDA eSTAR or notified body review: what reviewers check, common gaps and a checklist. 5 min read
Guide Also in Regulatory Affairs & Intelligence Regulatory Submission Management and Automation: eCTD, Tools and What to Automate How regulatory submissions are planned, assembled and published: eCTD 4.0 and eSTAR timelines, submission software, what to automate and AI review. 5 min read
Guide Also in Regulatory Affairs & Intelligence Regulatory Gap Analysis and Impact Assessment: A Practical Method for Life Sciences How to run a regulatory gap analysis in life sciences, with QMSR, EU reform and Annex 11 examples, how it differs from a government RIA, and a template. 5 min read
Guide Also in Supplier Quality & Assessment Supplier Evaluation and Qualification: A Step-by-Step Guide for GMP and Medical Devices A step-by-step supplier evaluation and qualification process for pharma and device makers: criteria, evidence, approval, requalification and FDA findings. 5 min read

Subjects covered

FDA compliance
FDA inspection
FDA 483
FDA warning letter
FDA audit
FDA inspection readiness
FDA compliance software
FDA regulatory compliance
FDA QMSR
ISO 13485
ISO 13485 compliance
ISO 13485 audit

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