MDR (EU 2017/745) impact on QMS

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:

1. Communication with stakeholders
2. Strategy for regulatory compliance
3. Person responsible for regulatory compliance
4. Sufficient financial liability
5. Risk management process
6. Clinical evaluation and investigation process
7. Vigilance and PMS process
8. UDI, labelling and EUDAMED
9. Technical documentation structure

• Importance of transition timeline

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