Regulatory/Legal
Jul 01, 2015
Two academics find that FDA is providing the right level of device regulatory oversight and posit that replacing some premarket clinical trials with postmarket...
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 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 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 04, 2015
Worried about a repeat of last year’s Open Payments data disaster? One expert has tips for medical device companies on how to make the data validation...
Jun 02, 2015
Here are some tips for medical device manufacturers to effectively implement the UDI rule and facilitate improved patient care and supply chain management....
Jun 01, 2015
An expert explains why it is worthwhile for suppliers to make software validation easier for medical device manufacturers. David A. Vogel, PhD Validation...
Jun 01, 2015
The call for improved medical device surveillance gets louder, with stakeholders pressing for public and private sector fixes in the name of device safety. Jim...