Dirigeants et représentants réglementaires de medicap clinic GmbH
SCHIFFCZYK Thomas
- Checking the conformity of the devices in accordance with the quality management system (QMS) before release;
- Preparing and maintaining the technical documentation and EU Declaration of Conformity
- Meeting post market surveillance obligations;
- Vigilance reporting and analysis requirements are met, including serious incidents, field safety corrective actions and report trending; and
- For investigational devices a signed statement that the device meets the GSPRs.