How to Establish Sustainable Validation for FDA & EU Compliance
Software validation is historically one of the most difficult compliance activit [...]
26
07, 2022
21
01, 2021
EU MDR Countdown: What’s Next for Medical Device Compliance
In four months, the new EU Medical Device Regulation (MDR) goes into effect, whi [...]
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 [...]
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 [...]
