All Roads Lead to ISO 13485: The Global Context
As regulations and standards evolve, one trend is continually sharpening in focu [...]
5
05, 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 [...]
13
06, 2017
Medical Device Manufacturers Warned For CAPA Non-Compliance
Three recent warning letters from the Center for Device and Radiological Health [...]
3
04, 2017
FDA Warning Letters Emphasize Document Control System Compliance
First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize [...]
16
12, 2016
Risk Management + Adverse Event Reporting: FDA Guidance
Risk management and adverse event reporting protocols for medical device manufac [...]
28
04, 2015
FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR
FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline [...]
24
11, 2014
FDA’s Local Offices Flex Regulatory Muscle
In our latest round-up, it was the District Offices turn to chime in on medical [...]
21
11, 2014
Are You Ready for 21st Century eMDR Submissions?
Jeff Mazik, Vice President, Life Science Solutions, AssurX If you have been pr [...]
13
08, 2014
FDA Guidance Advises Device Makers to Think About Home-Use
Medical device manufacturers would be well-advised to address any potential home [...]
