- Check device conformity in accordance with the QMS the company uses before the device is released,
- Ensure that technical documentation and EU documentation of conformity are generated and up-to-date.
- Ensure compliance to post-market surveillance obligations listed in Article 10(10) of MDR.
- Ensure that the company fulfills its reporting obligations, found in Articles 87-91 of MDR.
- Verify Statement from Section 4.1 of Chapter II of Annex XV of the MDR for investigational device.