Officers and regulatory representatives of Sutter Medizintechnik GmbH
SUTTER Bert
Responsibility under article 15 MDR primarily is that: - 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 and - the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date (Article 15 MDR, 3 (a) and (b)). The responsible person will also act as substitute / deputy for other appointed responsible persons under article 15 MDR.
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PESCHL Simone
Responsibility under article 15 MDR primarily is that: - the post-market surveillance obligations are complied with in accordance with Article 10(10) and - the reporting obligations referred to in Articles 87 to 91 are fulfilled (Article 15 MDR, 3 (c) and (d)). The responsible person will also act as substitute / deputy for other appointed responsible persons under article 15 MDR.