Officers and regulatory representatives of KC Struktur Kft. MF
DR. THIESZ Aletta
It ensures that the manufacturer:
- the conformity of the devices is properly checked under the quality management system applied during manufacture before the device is released for free circulation,
- prepare and keep up to date the technical documentation and the EU declaration of conformity,
- comply with post-market monitoring obligations,
- comply with post-market reporting obligations.