Regulatory/Legal
Jan 11, 2012
The OneMedPlace finance conference in San Francisco featured a panel discussion titled "AdvaMed 2012 CEO’s Unplugged: Global Outlook on Medical...
Jan 11, 2012
There is a lively debate going on in the Medical Devices Group on LinkedIn, which just reached a milestone of 80, 000 members. The topic up for discussion is...
Dec 18, 2011
While FDA (CDRH) and the medical device industry have a long history of antagonism, the relationship seemed to become especially sour in 2011. The agency has...
Dec 14, 2011
Not too long ago—a few decades to be somewhat imprecise, the healthcare industry in the United States was much less regulated than it is today, and was...
Dec 09, 2011
The device classification scheme is an important component of the U.S. regulatory system for medical technology. Introduced in the Medical Device...
Dec 08, 2011
At BIOMEDevice in San Jose, Andrew Kimmel, a partner at Knobbe Martens delivered a talk titled "IP Considerations During Product Development." Kimmel...
Dec 02, 2011
As the medical device industry continues to expand globally, it is increasingly important for device designers and manufacturers to ensure that their products...
Nov 29, 2011
Consistent with what one would expect as the 2012 election season barrels ahead, AdvaMed is directing ever more money toward political lobbying efforts....
Nov 23, 2011
I wrote a blog recently for our sister site, EMDT, where I discussed how many OEMs are going to Europe to design, test, and even sell their medical devices...
Oct 21, 2011
This should not be much of a surprise to anyone, but according to research done by the Minnesota Independent, Representative Erik Paulsen (R-MN) has...