What problem does it solve?
Medical device teams facing FDA inspections, internal QSR audits, or Form 483 responses need a structured way to pressure-test their quality system against 21 CFR 820 requirements before regulators do.
Core Features & Use Cases
- Six Forcing Questions: Systematically probes complaint/MDR handling, process validation (IQ/OQ/PQ), DHR completeness, CAPA effectiveness, labeling compliance, and Form 483 closure status.
- ISO 13485 Cross-Walk: Maps QSR findings against ISO 13485 clauses following the post-February 2026 harmonization, identifying FDA-specific overlays like labeling and MDR reporting.
- Structured Verdict Output: Produces an inspection-readiness report with a green/yellow/red verdict, top three actions with owners and FDA-cited timelines, and escalation flags for outside counsel.
- Use Case: Before an annual internal QSR audit, run the interrogation to sample DHRs, review aging CAPAs over 90 days, and verify MDR reporting timelines, then receive a gap list prioritized by regulatory risk.
Quick Start
Ask the AI to run an FDA QSR audit prep review on your medical device quality system scope, covering complaint files, process validation, DHRs, CAPAs, labeling, and any open Form 483 observations.
