EU IVDR 2017/746 POST-MARKET SURVEILLANCE TRAINING 28.06./27.07./11.10./25.11./21.12.2021
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Post-Market surveillance (PMS) serves as a key process in the IVDR. PMS will have additional requirements and undergo additional scrutiny in the incoming regulations.
In this training session, you will gain an understanding of how to gather, record and analyze relevant data on the quality, performance and safety of a device throughout its entire lifetime, specifically through insight on the changes in reporting responsibilities, including post-market surveillance follow-up (PMPF), to demonstrate conformity to the IVDR actively and systematically. The training also gives you an opportunity to discuss the various topics within post-market surveillance responsibilities with a subject matter expert whilst also receiving training evidence which demonstrates your competence.
• Opening remarks
• Introduction to IVDR
• Requirements presented under IVDR for PMS, including PMPF
• Considerations and common issues for PMS
• How to streamline your approach to PMS under IVDR
• Q&A session
• Closing remarks
- Start 02:00 PM – End 06:00 PM. Attendees are recommended to login 15 min in advance.
In order to keep the training interactive, the exact content schedule cannot be provided.
Certification:Personal Certificate will be provided in PDF
Presentation:Presentation will be provided in PDF