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ISO 13485 Post-Market Surveillance & Feedback Auditor

Audits medical device post-market surveillance feedback loops, customer complaints, and regulatory reporting procedures.

Notice: engineering verification utility. Use test or de-identified data and verify results independently before relying on them.

How it works

Standard: ISO 13485 Clause 8.2.1 Feedback & Clause 8.2.4 Complaint Handling

Formula: Verify complaint logging, investigation timelines, and customer feedback review records

Checks: Mandatory complaint handling metrics

Calculated locally in browser memory; nothing leaves your browser.

Deterministic local-first client-side execution. Provided as-is without warranty.