Air Liquide Italia Gas e Servizi S.r.l.

1. guarantee proper management of technical documentation, referring to drafting and updating; 2. guarantee that Declarations of UE conformity are drafted and updated; 3. guarantee that post marketing surveillance is performed according to MDR (UE) 2017/745, Article 10, paragraph 10

1. guarantee that devices' compliance is properly checked according to internal Quality Management System that rules medical devices manufacturing before release; 2. guarantee that reporting obligations are performed as stated in MDR (UE) 2017/745, Articles 87 and 91; 3. in case of medical devices subject to investigation, declaration according to MDR (UE) 2017/745, annex XV, chapter II, section 4.1 is released