Seramun Diagnostica GmbH

Article 15 (3 a, c, d) 3. The person responsible for regulatory compliance shall at least be responsible for ensuring that: (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; (c) the post-market surveillance obligations are complied with in accordance with Article 10(9); (d) the reporting obligations referred to in Articles 82 to 86 are fulfilled;

Art. 15 (3 b, e)