Dirigeants et représentants réglementaires de ASTON
LEVAUX Philippe
- the conformity of the devices, in accordance with the quality management system, before a device is released;
- the technical documentation and the EU declaration of conformity;
- the post-market surveillance obligations in accordance with Article 10(10);
- the reporting obligations referred to in Articles 87 to 91;
- in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV