CAPA
7 articles
SBOM-to-VEX Vulnerability Triage Workflow for Medical Devices: From CVE Intake to Field Action Decision
Operational playbook for medical device PSIRT teams — SBOM component matching, exploitability analysis, VEX justification authoring, PSIRT severity scoring, CAPA trigger thresholds, field safety corrective action decisions, and customer communication timing.
Quality Investigation for Medical Devices: Complaint, NCR, and Audit Finding Investigation Complete Guide
How to conduct quality investigations for medical devices — complaint handling, nonconformance investigation, audit finding root cause analysis, investigation methods, CAPA integration, and regulatory requirements under ISO 13485:2016, FDA 21 CFR 820, and EU MDR.
Quality KPIs and Metrics for Medical Devices: Complete Framework + ISO 13485 & QMSR 2026 Alignment
How to build a quality KPI framework for medical device companies — CAPA effectiveness, first pass yield, complaint rates, design control metrics, and cost of quality. Fully aligned with ISO 13485:2016 and FDA QMSR 2026 requirements.
Root Cause Analysis for Medical Devices: RCA Methods, Tools, and CAPA Integration
Complete guide to root cause analysis for medical device companies — 5 Whys, fishbone diagrams, fault tree analysis, Pareto charts, CAPA integration, and common mistakes that lead to FDA 483 observations.
Nonconformance Management for Medical Devices: Complete Guide to NCR, Disposition, and Regulatory Compliance
The complete guide to nonconformance management in medical device manufacturing — FDA 21 CFR 820.90, ISO 13485 clause 8.3, NCR writing, disposition options, Material Review Board, escalation to CAPA, root cause analysis, and common audit findings.
QMSR Gap Analysis for ISO 13485:2016 Certified Companies: The 50+ Item Checklist for FDA's New Quality System Rule
Clause-by-clause gap analysis checklist mapping ISO 13485:2016 to FDA's QMSR — covering terminology changes, complaint handling, labeling controls, UDI integration, record retention, and 50+ specific action items your QMS documents still need.
FDA Form 483 and Warning Letter Guide: How to Respond and Protect Your Medical Device Business
Learn how to respond to FDA Form 483 observations and Warning Letters for medical devices. Covers 2025-2026 enforcement statistics, top violations, response strategies, and the March 2026 draft guidance on 483 responses.