Dirigeants et représentants réglementaires de Gambro Industries
PONTET Caroline
(a) Ensuring the conformity of the device is checked in accordance with QMS before release.
(b) Ensuring the post-market surveillance obligations are met.
(c) Ensuring that the Declaration for investigational device used in clinical trials conforms to GSPR apart from aspects covered by the clinical investigations.
(d) Ensuring the reporting obligations relating to vigilance are met (ref. Article 87 to 91 of MDR).
(e) Ensuring technical documentation and EU DoC are drawn up and kept up to date.