IEC 60601-1
Top Medtech Stories in 2011: FDA, the Big Three, China, India, and the Future
Dec 06, 2011
We're getting closer to 2012, and it seems like a good time to look at what MD+DI articles resonated with you the most. This year, the stories fell into rather...
Medical Device Makers Should Act Now to Reduce Risk Amid Pending Changes to IEC 60601-1 Standard
Dec 01, 2011
By Nancy Duarte-Lonnroth The medical device industry’s anxiety over pending changes to the FDA’s 510(k) process is clear to see amid a slowly...
CDRH Officially Recognizes IEC 60601-1
Mar 11, 2010
CDRH is immediately recognizing IEC 60601-1, third edition. The announcement was made yesterday morning at the 20th annual AAMI/FDA international standards...