Dirigeants et représentants réglementaires de APIS
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WALKER Colette
IVDR 2017/746 Article 15:
Checking conformity of devices, in accordance with ISO 13485 :2016 before a device is released.
Drawing up and keeping up to date any technical documentation and EU DoCs
Completing post-market surveillance in accordance with Article 10(9)
Reporting obligations referred to in Articles 82 to 86.
Issuing Annex XIV statement, where devices for performance studies intended to be used in the context of interventional performance studies involving risks for the subjects