Dirigeants et représentants réglementaires de ASP International
TULEA Luminita
The manufacturer PRRC is at least responsible for ensuring the following:
- Device conformity is appropriately checked per ASP QMS.
- TS and EU DoC are kept up to date
- Post market surveillance obligations are compiled.
- Reporting obligations referred to in global regulations are fulfilled.
- In the case of investigational devices, confirm safety, performance and every precaution has been taken to protect the health and safety of subject.