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 [...]
3
04, 2020
Don’t take your foot off the gas on EU MDR implementation
The coronavirus has had a massive impact on the medical device industry. As a c [...]
10
03, 2020
The Six C’s of a Modern Complaint Management System 2020
Regulators such as FDA, European Commission (EC), ISO 13485 require a product c [...]
21
02, 2020
Human Error is a Precipitator for Root Cause Analysis, Not Blame
Have you ever been part of a process that had a failure or two? Perhaps you’ve b [...]
10
02, 2020
Assurx2020 Further Modernizes Efficiencies In Automating Quality Management
Morgan Hill, CA., January 22, 2020, – AssurX, Inc., a leader in enterprise quali [...]
5
02, 2020
AssurX Releases Manufacturing Incident Report Solution for EU MDR Report Automation for Medical Device Manufacturers
Morgan Hill, CA., February 5, 2020 – AssurX, Inc., a leader in enterprise qualit [...]
23
01, 2020
Configuration vs. Customization for Enterprise QMS Software
Experience shows that out-of-the-box configured software only works for business [...]
