EU MDR Countdown: What’s Next for Medical Device Compliance
In four months, the new EU Medical Device Regulation (MDR) goes into effect, whi [...]
21
01, 2021
19
01, 2021
Addressing the EU MDR and IVDR Certification Bottleneck
With the May 26, 2021 implementation deadline looming for the new EU Medical Dev [...]
11
01, 2021
EU MDR Compliance Check-in: Challenges and Action Items
The new EU Medical Device Regulation (MDR) goes into effect in less than six mon [...]
3
12, 2020
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 n [...]
29
10, 2020
Revasum Implements AssurX Solution for Semiconductor Issue Management
FRACAS solution will help identify platform-based issues and drive reliability p [...]
6
10, 2020
Implementing Your Automated Compliance Management System
This article is the final of a three-part series, “Selecting an Automated Compli [...]
1
10, 2020
Best Practices for Compliance Software Requirements Gathering and Vendor Shortlisting
This article is the second of a three-part series, “ Selecting an Automated Comp [...]
21
09, 2020
Selecting a Compliance Management Software: Preparation is the Key to Success
This article is the first of a three-part series, “ Selecting an Automated Compl [...]
14
09, 2020
AssurX Focuses on Medical Device Compliance at RAPS Convergence 2020
AssurX is participating in the first virtual RAPS Convergence Conference current [...]
4
08, 2020
Why Consider a Cloud QMS for FRACAS Automation?
Authors: Sal DiIorio, Principal Consultant, Semi-Tech Group Dave Vadas, VP of Sp [...]
