Regulatory and Compliance
May 25, 2017
Heather R. Johnson On April 18, lawyer Dillon Brozyna of Edelson PC, on behalf of lead plaintiff Joan Richards of Utah, filed a class action against MDLive, a...
May 07, 2017
Here's how a recent D.C. Circuit Court ruling will impact faxing, which remains essential to the medical device industry because doctor’s offices, hospitals,...
May 04, 2017
Critics worry that the law could allow unsafe medical devices to come to market, but there are a couple of things they don’t understand. Matthew M. Lowe The...
Apr 25, 2017
'Intended use' and 'indications for use' are two terms that are often mistakenly treated as interchangeable. Jon Speer     The medical device...
Apr 13, 2017
A recent court decision in a case involving Intuitive Surgical serves as a useful reminder for medical device manufacturers to review their approach to...
Apr 06, 2017
Here are the four critical questions to ask before taking on the literature search and review process. Scott Ahlberg Whether your organization is about to...
Apr 04, 2017
Medical device makers are uniquely affected by the 21st Century Cures Act, including at least one immediate impact. Here's what you need to know. Brian...
Mar 23, 2017
This primer will help medical device manufacturers that are already familiar with RoHS gain a better understanding of the European Chemical Agency’s REACH...
Feb 23, 2017
Cybersecurity is a concern for connected medical devices, but not all risks are apparent—or materialize—until after a product is on the market. FDA therefore...
Feb 22, 2017
An expert discusses what medical device manufacturers need to keep in mind as the compliance date for the fourth edition of the IEC 60601-1-2 standard...