Keystone Heart

The conformity of the devices in accordance with the quality management system under which the devices are manufactured. The technical documentation and the EU declaration of conformity The post-market surveillance obligations are complied with in accordance with Article 10 (10). The reporting obligations referred to in Articles 87 to 91 are fulfilled. In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

The conformity of the devices in accordance with the quality management system under which the devices are manufactured. The technical documentation and the EU declaration of conformity The post-market surveillance obligations are complied with in accordance with Article 10 (10). The reporting obligations referred to in Articles 87 to 91 are fulfilled. In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.