This webinar, hosted by Greenlight Guru, focuses on preparing quality management systems (QMS) for the EU Medical Device Regulations.
Watch now to learn about the critical updates required for compliance, including complaint handling, documentation, UDI and EUDAMED integration, and specific needs for implantable devices.
Main points covered:
1. Overview of the new regulation and its implications for medical device manufacturers.
2. Insights into developing a compliance strategy that aligns with the EU MDR requirements.
3. Changes in documentation, reporting standards, and how to align current practices with the new requirements.
4. Enhancements needed in risk management and post-market surveillance to meet the EU MDR standards.
5. Requirements for clinical evaluation and the collection of clinical evidence under the EU MDR.
6. Specifics on updating a QMS to comply with the new regulations, including changes in procedures and policies.
Target Audience:
• Medical Device Executives
• Regulatory Affairs Professionals and Management
• Quality Professionals and Management
• Clinical Affairs Professionals and Management
• R&D Engineers and Management
Access the printable slides for this presentation by visiting:
https://www.greenlight.guru/webinar/p...
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