Officers and regulatory representatives of Euroresearch S.r.l.
FANETTI Caterina
- Verify that device conformity is adequately controlled in accordance with the quality management system prior to the release of a device
- Verify that technical documentation and EU Declaration of Conformity are drafted and updated
- Ensure that post-market surveillance obligations as outlined in Art.10(10) are met
- Confirm that reporting obligations as described in Art. 87-91 are met
- For investigational devices, verify that declaration specified in Annex XV, Chapter II, point 4.1 is issued