CAPA & Complaint Management
Corrective and preventive action, root cause analysis and effectiveness checks, complaint handling and post-market surveillance.
16 articles
- 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.
- CAPA Effectiveness Check Template for Medical Device and GMP Teams CAPA was FDA's top device 483 citation in FY2025. Use this CAPA effectiveness check template to set criteria, measure results and close with evidence.
- 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.
- 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.
- CAPA Management and CAPA Software: Automation, AI and What to Look For in 2026 How to manage CAPA well and what CAPA software should do in 2026: KPIs, automation, AI with human review, validation under FDA CSA, and a selection checklist.
- CAPA Root Cause Analysis and Investigations: Methods, Pitfalls and What FDA Expects How to run a CAPA investigation that finds the real root cause: methods like 5 Whys, fishbone and FMEA, the human error trap, and what FDA warning letters reveal.
- CAPA Audit and Effectiveness Checks: How to Prove Your CAPA System Works How auditors and FDA investigators evaluate a CAPA system, how to design effectiveness checks that prove actions worked, and a CAPA audit checklist.
- 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.
- Complaint Management Systems and Software for Regulated Companies: Requirements, AI and Selection What complaint management requires in FDA-regulated industries, what complaint handling software should do, how AI can help triage, and a selection checklist.
- Adverse Event Reporting in the US: FDA Requirements for Drugs and Devices in 2026 FDA adverse event reporting explained: device MDR 30-day and 5-day reports, drug 15-day Alert reports, MedWatch forms, eMDR and the new AEMS system.
- 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.
- 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.
- 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.
- Supplier Corrective Action Requests (SCAR): How Supplier CAPA Should Work How to issue and manage supplier corrective action requests in pharma and devices: when to raise a SCAR, what a good response holds and how to verify it.
Subjects covered
- CAPA
- corrective and preventive action
- CAPA management
- CAPA software
- CAPA automation
- CAPA investigation
- CAPA effectiveness check
- CAPA root cause analysis
- CAPA compliance
- CAPA audit
- complaint management
- medical device complaint management