Preparing for a voluntary recall
In the world of developing products and getting them out to consumers, the last thing anyone wants is a recall. Planning for a recall may seem almost...
Certifying the supply chain to ISO 13485
Medical-device manufacturers seeking ISO 13485:2003 certification must undergo a review of their entire quality system. At the same time, all outsourced...
Industry upset about Patent Reform Act
The House of Representatives recently passed the Patent Reform Act by a vote of 220 to 175. The narrowly approved legislation includes numerous amendments...
Is patent reform the answer?
Problems at the U.S. Patent Office affect medical-device businesses on both sides of the patent fence. Businesses trying to protect their innovations...
FDA studies electronic MDRs
The FDA is working on an electronic submission program called eMDR, which will let companies submit MDRs (medical device records) to the Agency. Working...
MDUFMA 2: A half-step in the right direction
Medical-device makers must be ignoring their lobbyists. What else could explain the Medical Device User Fee and Modernization Act, more commonly called...
Bringing legacy devices into compliance
There are no standard guidelines for changing legacy medical products, but there are proven approaches. The best of these include the expectations of...
Are patents worth their bother?
New research and rulings by the U.S. Supreme Court might make companies and inventors wonder if patents are worth the trouble to file. The debate is fueled...
FDA proposes MDUFMA II
The FDA proposed recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA II). Under the medical-device...
4 intellectual-property issues will affect your company
The old saw says you are what you eat. For high technology-companies that make up the medical-device industry, it appears that you are what you create....
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