Dirigeants et représentants réglementaires de Ortrud
NILSSON Patrik
- Conformity of the device to the manufacturer’s QMS prior to release
- Technical documentation and EU Declaration of Conformity
- Post-market surveillance obligations follow Article 10(10), Article 83
- Reporting obligations referred to in Articles 87 to 91 are fulfilled
- The statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the case of investigation devices