Training objectives:
The following skills and competencies are developed:
- Understanding the EU regulation for medical devices
- Identifying applicable MDR requirements and the impact on the QMS
Training content:
- Registration of economic operators & their obligations
- Registration of devices
- New product classification and conformity assessment procedures
- Review and definition of changes / new requirements regarding QMS, in particular:
- Communication with stakeholders
- Strategy for regulatory compliance
- Person responsible for regulatory compliance
- Sufficient financial liability
- Risk management process
- Clinical evaluation and investigation process
- Vigilance and PMS process
- UDI, labelling and EUDAMED
- Technical documentation structure
• Importance of transition timeline