Officers and regulatory representatives of UNEEG medical A/S
WISMAR Camilla
- conformity of devices is appropriate checked before a device is released;
- technical documentation/EU declaration of conformity are drawn up and kept up to date;
- the post-market surveillance obligations are complied with;
- the vigilance reporting obligations are fulfilled:
- in case of investigational devices, a statement is signed to ensure that device in question conforms to the GSPR's apart from the aspects covered by the clinical investigation.