Officers and regulatory representatives of ARMEDICAL S.C.
SEDELINI RAFAŁ
OWNER.
- he conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are anufactured, before a device is released
- he technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
- the post-market surveillance obligations are complied with in accordance with Article 10(10)
- he reporting obligations referred to in Articles 87 to 91 are fulfilled