EU MDR Compliance Check-in: Challenges and Action Items
The new EU Medical Device Regulation (MDR) goes into effect in less than six mon [...]
11
01, 2021
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 [...]
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 [...]
28
07, 2020
Prioritize QMS Process Automation or Risk Failure
This blog is part of a three-part series on proven strategies to help avoid QMS [...]
13
07, 2020
A Successful QMS Implementation Requires Clearly Defined Processes
This blog is the second of a three-part series on QMS implementation best practi [...]
13
07, 2020
Avoid QMS Implementation Failures with the Right Team
This blog it the first of a three-part series on QMS implementation best practic [...]
1
06, 2020
How Risk-Based Testing is Revolutionizing Computer System Validation
We live in a world where speed is vital to success. Patients and consumers expe [...]
14
05, 2020
Effectively Managing Data Integrity for CGMP
Data integrity is a key component in making informed decisions within any organi [...]
