Medtech Quality
Audit readiness for medical device and SaMD startups
Design controls, risk files and software lifecycle records built with your team before the first ISO 13485 or MDSAP audit, plus independent internal audits.
| Need | Description | Verification | Status |
|---|---|---|---|
| UN-02 | Device alerts the user when a sensor fails | VER-12 | Traced |
| UN-03 | Patient data is encrypted in transit | missing | Gap |
