Regulatory and Compliance
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...
Feb 03, 2017
Marie Thibault In what is a significant step for the effort to add unique device identifiers (UDIs) to health insurance claims forms, on February 1 the...
Jan 03, 2017
Device manufacturers may find themselves advocating equivalence to FDA for the 510(k) process while also differentiating their product from the same device in...
Dec 29, 2016
Marie Thibault CDRH has publicized its resolution list for the new year, issuing an A-list of its top priorities for final and draft guidance in fiscal year...
Dec 16, 2016
Considering what FDA and medtech regulation may look like under the incoming administration. Jim Dickinson Emerging like the campaign that preceded it as the...