EU MDR: Compliance Requirements From a Vigilance Perspective

admin.veranex : Mar 24, 2025 10:23:11 PM

Data Management & Analytics

 

Companies attempting to comply with Medical Device Regulation (EU) 2017/745 (MDR), introduced in May 2021 for medical device certification in the EU are challenged by the complexity and scope of the requirements. It is important for medical device companies to understand the latest requirements in the EU MDR, to minimize the risk of non-compliance and inability to certify products in the EU.


 

Webinar: Leveraging FDA Clearance/Approval for Successful EU MDR Submissions

Gary Keeler : Mar 24, 2025 10:23:11 PM

The transition phase to MDR (Regulation (EU) 2017/745) has been underway since mid-2020 and has introduced new requirements for medical...

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Medical Device Vigilance: Important Considerations to Comply With the EU MDR

Gary Keeler : Mar 24, 2025 10:23:09 PM

Vigilance reporting and postmarket surveillance of medical devices are among the many requirements documented in the EU MDR (2017/745) to ensure the...

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AI Medical Devices: Your Comprehensive Guide to Development and Documentation

3 min read

AI Medical Devices: Your Comprehensive Guide to Development and Documentation

Heather Antonovich : Mar 24, 2025 10:22:42 PM

The integration of artificial intelligence into medical devices represents a transformative shift in healthcare technology. Yet, for...

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