Regulatory and Compliance
Jun 29, 2016
Marie Thibault New findings published by The BMJ may give some proponents of speedy device approvals pause. It's well-known that high-risk medical devices...
Jun 27, 2016
FDA cited device-design issues as one reason medical device recalls are on the rise. Here’s how manufacturers can stop these problems from reoccurring. Joshua...
Jun 23, 2016
FDA and other global regulatory bodies have been busy in 2016. These are some of the biggest regulatory developments so far this year.  Marie Thibault In...
Jun 22, 2016
Medical device postmarket surveillance is under a new spotlight, and it’s critical for manufacturers to identify requirements that relate to them and stay on...
Jun 20, 2016
The ISO 13485:2016 update will have a significant impact. Here's what medical device manufacturers need to know. Bart Reitter In March, the International...
Jun 17, 2016
Physicians are identifying flaws in regulatory oversight of medical devices and publicizing their findings. Jim Dickinson The FDA regulatory scheme for...
Jun 16, 2016
Marie Thibault Recognizing the fast pace of advancement in software development, FDA is searching for the best way to regulate higher-risk medical software...
Jun 06, 2016
FDA's draft guidance addresses considerations for additive manufacturing in medical devices, but stops short of answering some key questions. Yarmela Pavlovic...
Jun 01, 2016
Marie Thibault For more than two decades, FDA has been categorizing investigational medical devices as either Category A (experimental/investigational) or...
May 27, 2016
Marie Thibault Women's health devices have been in the spotlight in recent years for all the wrong reasons. Laparoscopic power morcellators fell out of favor...