Life Sciences | AssurX

Addressing the EU MDR and IVDR Certification Bottleneck

AssurX Blog2021-01-19T07:00:36+00:00January 19th, 2021|

With the May 26, 2021 implementation deadline looming for the new EU Medical Device Regulation (MDR), medical device com [...]

AssurX Blog2021-01-11T07:36:20+00:00January 11th, 2021|

The new EU Medical Device Regulation (MDR) goes into effect in less than six months, leaving little time for medical dev [...]

AssurX Blog2024-01-13T02:07:39+00:00December 3rd, 2020|

After a one-year delay due to concerns over a shortage of notified bodies, the new EU Medical Device Regulation (MDR) is [...]

AssurX Blog2020-09-14T13:37:58+00:00September 14th, 2020|

AssurX is participating in the first virtual RAPS Convergence Conference currently live through September 16, 2020, in V [...]

AssurX Blog2020-08-04T05:30:39+00:00August 4th, 2020|

Authors: Sal DiIorio, Principal Consultant, Semi-Tech Group Dave Vadas, VP of Special Projects, AssurX Quality ma [...]

AssurX Blog2020-07-28T07:50:20+00:00July 28th, 2020|

This blog is part of a three-part series on proven strategies to help avoid QMS implementation failures. The first blog [...]