Officers and regulatory representatives of Occlutech GmbH
SCHMIDT Alexander
According to Regulation (EU) 2017/745, article 15,3(a):
- 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
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WEBER Andrea
According to Regulation (EU) 2017/745, article 15,3(b):
- the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
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KLEBON Susann
According to Regulation (EU) 2017/745, article 15,3(c), (d), (e):
- the post-market surveillance obligations are complied with in accordance with Article 10(10) of (EU) 2017/745
- the reporting obligations referred to in Articles 87 to 91 of (EU) 2017/745 are fulfilled
- in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of (EU) 2017/745 is issued