Dirigeants et représentants réglementaires de Saagha
ROBERT Marylise
According to REGULATION EU 2017/745:
- the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
- the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
- the post-market surveillance obligations and reporting obligation are fulfilled;
- in the case of investigational devices:compliance of the required statement.