Simulation Module · EU MDR 2017/745
Licensing
Run your medical device technical file through a notified-body-grade audit simulation before you submit it. Find the gaps, fix them, and have each fix reviewed against the finding it closes.
License models
Monthly audit access that scales with your workload
Single
1 audit simulation / month
- Full-scope audit across all applicable requirements
- Cross-document consistency check
- Findings report with clause-level references
- Finding Resolution — your corrections reviewed against each finding
Team
5 audit simulations / month
- Everything in Single, applied to every file
- Each file gets its own workspace, findings, and Finding Resolution
- Better per-file economics
Scale
10 audit simulations / month
- Everything in Team
- Highest monthly throughput
- Priority support
Enterprise
Custom volume · dedicated deployment · tailored standard packages
For consultancies and larger teams running high audit volumes, or organizations that need a dedicated environment configured to their scope.
Pilot program
Become a Pilot Partner
We're opening a limited pilot to a small number of EU MDR device manufacturers and consultants, across all risk classes. Whether the device is active or non-active makes no difference.
- First 3 partners only
- 8 weeks, up to 3 files
- Finding Resolution included for each file
- In exchange: structured feedback after each run + your consent to serve as a reference (named or anonymous)
Get started
See it on your own technical file
Leave your details and we'll reach out to discuss how ReGentra applies to your technical documentation.