What problem does it solve?
Medical device quality teams often enter ISO 13485 internal audits, MDR reviews, or FDA QSR alignment checks without systematically verifying design controls, CAPA effectiveness, and post-market surveillance evidence, leading to avoidable audit findings.
Core Features & Use Cases
- Six-Question Forcing Interrogation: Systematically probes DHF completeness, CAPA effectiveness verification, process validation (IQ/OQ/PQ), risk management files per ISO 14971, post-market surveillance, and Clause 5.6 management review evidence.
- Structured Readiness Verdict: Produces a standardized audit prep report with sampled DHF status, CAPA health metrics, cross-framework impact (EU MDR, FDA QSR, ISO 42001), and a READY / CLOSE-DHF-GAPS-FIRST / NOT-READY verdict with top three corrective actions.
- Use Case: Before a Clause 8.2.4 internal audit, a quality manager runs the interrogation across three sampled DHFs and the last five CAPAs, receives a gap list with owners and timelines, and routes CAPA deep-dives to the capa-officer tooling.
Quick Start
Run /cs:iso13485-audit-prep with your audit scope to pressure-test QMS readiness before the upcoming internal audit.
