Regulatory Affairs: EU MDR/IVDR and FDA eIFU compliance without manual chaos
Standardize release control, revision visibility, and multilingual access with a workflow built for medical device and IVD regulatory teams.
EU MDR/IVDR workflow support
- Multilingual eIFU delivery for EU market use.
- Revision-aware publishing to keep current IFU versions accessible.
- Documentation practices aligned to MDR and IVDR expectations.
US FDA workflow support
- Structured document access designed for FDA-regulated environments.
- Controlled update flow to reduce risk from outdated instructions.
- Traceable distribution for cross-functional teams and audits.
Best fit for Regulatory Affairs teams that need to:
Reduce release friction
Replace repetitive manual document handling with a controlled, repeatable process.
Improve update confidence
Ensure users can always access the latest approved IFU version.
Support multi-market growth
Scale document delivery for EU and US teams from one workflow foundation.
Shorten audit preparation time
Keep release history and revision visibility organized and review friendly.