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Addressing the EU MDR and IVDR Certification Bottleneck
With the May 26, 2021 implementation deadline looming for the new EU Medical Device Regulation (MDR), medical device com [...]
EU MDR Compliance Check-in: Challenges and Action Items
The new EU Medical Device Regulation (MDR) goes into effect in less than six months, leaving little time for medical dev [...]
How to Meet New EU MDR Requirements for Vigilance and Reporting
After a one-year delay due to concerns over a shortage of notified bodies, the new EU Medical Device Regulation (MDR) is [...]
Revasum Implements AssurX Solution for Semiconductor Issue Management
FRACAS solution will help identify platform-based issues and drive reliability projects AssurX, Inc., a leader in enterp [...]
Implementing Your Automated Compliance Management System
This article is the final of a three-part series, “Selecting an Automated Compliance Management Software Platform.” Pa [...]
Best Practices for Compliance Software Requirements Gathering and Vendor Shortlisting
This article is the second of a three-part series, “ Selecting an Automated Compliance Management Software Platform.” [...]
