CAPA
9 articles
VetMedGuide: Building a Useful Veterinary Device Field-Feedback Form
A manufacturer intake worksheet for veterinary analyzer complaints: separate instrument observation, species and matrix, clinic QC evidence, and unsupported causality.
FDA Consent Decrees of Permanent Injunction for Medical Device Manufacturers (2026)
Comprehensive guide to FDA consent decrees of permanent injunction under FD&C Act Section 302, sign-or-sue letters, CGMP remediation, executive liability, case studies, and recovery strategies.
SBOM-to-VEX Vulnerability Triage Workflow for Medical Device PSIRTs
PSIRT playbook for medical device SBOM-to-VEX triage, covering CVE intake, component matching, exploitability analysis, VEX rationale, severity scoring, CAPA, field action, and communications.
Medical Device Quality Investigation Guide: Complaints, NCRs, and Audit Findings
Conduct medical device complaint, NCR, and audit finding investigations with root cause methods, CAPA, and ISO 13485, FDA 21 CFR 820, and EU MDR alignment.
Quality KPIs and Metrics for Medical Devices: ISO 13485 and QMSR Guide
Build medical device quality KPIs for CAPA effectiveness, first pass yield, complaints, design controls, cost of quality, and ISO 13485 and QMSR alignment.
Root Cause Analysis for Medical Devices: RCA Methods, Tools, and CAPA Integration
Guide to medical device root cause analysis, covering 5 Whys, fishbone diagrams, fault tree analysis, Pareto charts, CAPA links, and FDA 483 risks.
Nonconformance Management for Medical Devices: NCR, Disposition, and CAPA
Medical device nonconformance management covering FDA QMSR, ISO 13485 clause 8.3, NCR writing, disposition, MRB review, CAPA escalation, and audit findings.
QMSR Gap Analysis for ISO 13485 Companies: 50+ Item Checklist
Use this QMSR gap analysis checklist to map ISO 13485:2016 processes to FDA requirements for terminology, complaints, labeling, UDI, records, and action items.
FDA Form 483 and Warning Letter Response Guide for Medical Devices
Guide to responding to FDA Form 483 observations and Warning Letters for medical devices, including 2025-2026 enforcement trends, top violations, response strategy, and draft guidance.