All Roads Lead to ISO 13485: The Global Context
As regulations and standards evolve, one trend is continually sharpening in focu [...]
As regulations and standards evolve, one trend is continually sharpening in focu [...]
After a one-year delay due to concerns over a shortage of notified bodies, the n [...]
Three recent warning letters from the Center for Device and Radiological Health [...]
First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize [...]
Risk management and adverse event reporting protocols for medical device manufac [...]
FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline [...]
In our latest round-up, it was the District Offices turn to chime in on medical [...]
Jeff Mazik, Vice President, Life Science Solutions, AssurX If you have been pr [...]
Medical device manufacturers would be well-advised to address any potential home [...]