HUMAN EXPERT REVIEW SERVICES

Need Help With Your First RMF?

Share a non-confidential description of your medical device. The MedMI team will help you prepare and review your first structured RMF draft.

RMF Structure & Draft

Ideal for early-stage startups mapping out their first device characteristics.

₹15,000

✔ Device profile alignment
✔ Initial hazard list setup
✔ Formatted Word export draft

Recommended

RMF Draft + Expert Review

Perfect for teams preparing CDSCO, CE MDR, or FDA submissions.

₹35,000

✔ Complete hazard & sequence draft
✔ Mitigation controls verification
✔ Review by Lead QA/RA Auditor
✔ Full Word, Excel, & PDF output

RMF + Software & Usability

For complex active, electrical, or software-controlled medical devices (SaMD).

₹60,000 to ₹75,000

✔ Full ISO 14971 RMF preparation
✔ IEC 62304 Software risk mapping
✔ IEC 62366 Usability matrix setup
✔ Audit support ready

Request Assisted RMF Review

You have selected: RMF structure and draft (₹15,000)

Liability Disclaimer: MedMI assists in preparing structured medical device risk management documentation. Final review, approval, regulatory use, and compliance responsibility remain with the medical device manufacturer.