Regulatory and Compliance
Jun 30, 2015
Academic research points to FDA as the regulator with the appropriate amount of oversight for medical devices. Marie Thibault There's a surprising finding in...
Jun 29, 2015
Thinking about bringing your medical device to Canada? Get familiar with the basics of Health Canada regulations. Don Boyer In the almost 25 years I spent...
Jun 29, 2015
Marie Thibault   If you thought the definition of a "surgical gown" was obvious, think again. FDA has set out its policy on what is and is not a...
Jun 25, 2015
In an analysis of FDA approvals for medical device PMAs, one state is the obvious winner, with the shortest time to approval. Which state is home to the...
Jun 24, 2015
Marie Thibault FDA has published draft guidance to give industry a better idea of what the agency looks at when deciding whether to approve an Investigational...
Jun 23, 2015
Is FDA becoming super fast in approving complex devices. The answer appears to be yes.  Arundhati Parmar A lot has been said about FDA over the years....
Jun 19, 2015
Knowing the ins, outs, ups, and downs of the standards that apply to your product is paramount. Alena Mitchell I have worked as a safety engineer in the...
Jun 19, 2015
Researchers criticize the current administration for lack of transparency because of the dearth of oversight of FDA guidance documents. At the same time,...
Jun 15, 2015
An industry survey finds that more than half of surveyed medical device companies conduct early feasiblity studies outside the United States. What's needed to...
Jun 11, 2015
Marie Thibault   Various stakeholders have banded together to encourage legislators to push for the addition of implantable medical device unique device...