Importers and distributors. Your obligations, in one place.
Companies that import or distribute medical devices but are not the legal manufacturer. Under EU MDR they carry their own obligations (Articles 13 and 14).
Pain points
What gets in the way.
- Verifying CE marking, labelling and documentation for each device.
- Recording and forwarding complaints and field safety actions to manufacturers.
- Keeping traceability and storage records ready for authorities.
How OPRA Flow helps
One platform, built for this stage.
- OPRA Docs
- Keep verification checklists and supplier records under control.
- OPRA Events
- Log complaints and pass them to the manufacturer with a full trail.
- OPRA Train
- Show staff are trained on handling and storage.
Where to begin
Start small. Grow on the same platform.
- Begin with
- OPRA Docs and OPRA Events
- Grow into
- OPRA AI
Other segments