Medical Device QMS Gap Review
Clause-referenced gap review of CAPA, complaints, design controls, and risk files against ISO 13485, FDA QMSR, and ISO 14971.
Before & after
Same prompt, same agent — the only difference is the skill.
I can help you review your CS team's processes and compliance posture. What specific regulations do you need to follow in your industry? What quality standards matter most to your business? I'd recommend examining response times, customer satisfaction scores, and documentation practices carefully. We should probably audit your support tickets and systems too. Do you have a specific compliance concern or concern area, or should I do a broader general review of everything?
CS TEAM AUDIT — COMPLIANCE & QUALITY REPORT: REGULATORY FRAMEWORK: SOC 2 Type II certification required. GDPR compliance if serving EU customers. CCPA compliance for California residents. COMPLIANCE STATUS & CHECKLIST: CHECK 1 — Customer data access logging: PASS. Zendesk audit trail enabled and functioning, retention window 90 days configured. CHECK 2 — Data retention policy documented: FAIL. Missing written documented policy defining retention window (recommend 7 years for regulatory compliance alignment). CHECK 3 — Incident response plan: PASS. Plan documented and exists but not tested in 18 months. Recommend annual tabletop exercise. CHECK 4 — CS team background verification: FAIL. No documentation of background checks completed. Required for SOC 2 attestation. Action: Complete background checks by 2026-08-31. QUALITY METRICS & PERFORMANCE: First Response Time (SLA target 4 hours): Current 5.2 hours average. Gap of 1.2 hours over SLA. Fix: Route high-priority tier-1 tickets to morning shift only. Customer Satisfaction Score: 78%. Industry benchmark 82%. Root cause: Knowledge base content outdated (last update 2025-11-01). Action: Refresh KB entirely, due 2026-08-15. Ticket Resolution Time (SLA target 48 hours): Current 61 hours average on complex multi-step tickets. Fix: Add tier-2 escalation workflow, reduce stuck-ticket backlog. HIGH-PRIORITY ACTIONS (30 days): Write data retention policy, complete background checks, refresh knowledge base completely, test incident response plan.
About this skill
Audit findings in medical device quality systems cluster in the same places: CAPA, complaints, design controls, suppliers, and risk management. This skill reviews your procedures and records the way a lead auditor would and grades what it finds.
What it does
- Reviews against ISO 13485:2016, FDA's QMSR (21 CFR 820 incorporating ISO 13485), and ISO 14971:2019, scoped to your markets
- Applies 15 auditor-level checks: CAPA root causes and effectiveness, complaint reportability rationale, risk file feedback loops, design traceability, QMS software validation, supplier controls, process validation, calibration impact
- Separates procedure review (does the system meet the standard) from record review (is it followed)
- Grades findings major or minor and verifies prior finding closure with evidence
- Flags every date, deadline, and interpretation to verify against current official text
What you get
A clause-referenced findings table with objective evidence and recommended corrective action, a prior-findings closure check, likely audit-day samples, and a list of items for your RA/QA professional to confirm.
Best for
QA/RA managers and startups preparing for ISO 13485 certification or surveillance audits, MDSAP, notified body audits, or FDA inspections. Supports, but does not replace, a qualified auditor.
SKILL.md preview
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name: medical-device-qms-gap-review
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