Compliance with Ensure that Technical Documentation and EU Declaration of Conformity are drawn up and kept up to date.
Sign off Regulatory Affairs related non-conformities (e.g. Technical File discrepancies, Regulatory Affairs procedure related non-conformities).
Regulatory oversight of compliance with applicable MDR requirements and support of device regulatory submissions and maintenance activities.
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PASTOR Caroline
Compliance with Post Marketing Surveillance obligations in accordance with EU MDR Art. 10(10) Fulfillment of reporting obligations referred to in EU MDR Articles 87 to 91 Sign off Safety related non-conformities
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DAUDE Gaelle
Appropriate check of the conformity of the devices, in accordance with the quality management system under which the devices are manufactured, before a device is released. Sign off Quality Assurance related non-conformities ( eg Production related findings, Out of specifications, Release/Rework/quarantine shipment, Supply, Quality Complaints) Sign off MCRM (Monthly Review of Quality Complaints)
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ARTUS-ARDUISE Cécile
Sign off documentation related to investigational devices as per EU MDR Section 4.1 of Chapter II of Annex XV requirement: