Officers and regulatory representatives of Willy-Rusch GmbH
MULLER-HOFFMAN Annette
QMS: the conformity of the devices is appropriately checked, in accordance with the quality management system under, which the devices are manufactured, before a device is released.
PMS: the post-market surveillance obligations are complied with in accordance with Article 10 (10) of The Regulation.
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SCHMIDT Manual
Vigilance: the reporting obligations referred to Article 87 to 91 of The Regulation are fulfilled.
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STOYKOV Rostislav
Regulatory Affairs: the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; In the case investigational devices, ensuring that the statement referred to in Section 4.1 of Chapter II of Annex XV of The Regulation is issues.