Officers and regulatory representatives of Ritter Concept GmbH
NIZIAIEVA Olha
- 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