Regulatory Outlook
May 21, 2013
In January of 2013, the wishes of Agile fans writing software for medical devices finally came true—FDA added AAMI TIR45:2012, “Guidance on the use...
May 14, 2013
By Gil Zweig, President, Glenbrook Technologies Over the years, FDA has issued a number of documents that provide guidance for industry and FDA staff, with...
Mar 01, 2013
Having a basic understanding of patent law is more important to those in the medical device and diagnostics industry now than it has ever been. Major recent...
Jan 08, 2013
By following best practices for labeling companies can also take greater advantage of the flexibility offered by electronic labeling.  Image...
Jan 07, 2013
 According to FDA, 21 CFR Part 820.50—Purchasing Controls continues to be a significant concern for device manufacturers The agency reports...
Oct 15, 2012
In August, we released the first segment in a series that addresses what engineers need to know about the medical device regulatory process from a design and...
Aug 30, 2012
It was an emotional moment for me and my client William Heppner (former Stryker Biotech vice president of sales) earlier this year, when the U.S. Department of...
Aug 23, 2012
Medical device companies have one primary goal: to develop, manufacture and market a medical device that addresses an unmet market need. While it’s a...
Jul 13, 2012
Referral communication within the healthcare setting is often one-way, damn near impossible to track, and sometimes does not include the required patient...
May 19, 2012
Consider these common scenarios: an acquisition or carve-out occurs, and a medical device has a new manufacturer, or a manufacturer decides to change its name...