groupe lépine

- the conformity of all Groupe Lépine medical devices, and associated QMS - product release - manufacture - the technical documentation and the EU declaration of conformity - the post-market surveillance obligations - the reporting obligations (more details on Article 15 of the Medical Device Regulation)

PRRC DEPUTY for : - the conformity of the devices is properly verified, in accordance with the quality management system under which the devices concerned are manufactured, before a device is released; - the notification obligations referred to in Articles 87 to 91 are fulfilled; - in the case of devices under investigation, the declaration referred to in Annex XV, Chapter II, Section 4.1 is issued.

PRRC DEPUTY FOR : - technical documentation and the EU declaration of conformity are drawn up and kept up to date; - post-marketing surveillance obligations are fulfilled, in accordance with Article 10, paragraph 10;