AssurX Blog
Straight talk for regulated industries.
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 companies are under pressure to ensure products are compliant with [...]
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 device manufacturers to bring products into compliance. The new law [...]
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 set to take effect as of May 26, 2021. The regulations are a de [...]
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 enterprise quality management and regulatory compliance software, anno [...]
Implementing Your Automated Compliance Management System
This article is the final of a three-part series, “Selecting an Automated Compliance Management Software Platform.” Part I and Part II of this series have provided best practice guid [...]
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.” Requirements gathering is central to the success of the complian [...]
