This article was written by Leo Eisner and is featured in the Journal for Medical Device Regulations in their May 2012 edition. It is the top article on our Featured Articles WebPage. This article is on the National Implementations of IEC 60601-1:2005 for the EU under the MDD & AIMDD, Canada under the purview of Health Canada via the Canadian Medical Device Regulations (CMDR), United States of America under the purview of the Food & Drug Administration (FDA), and Brazil under the purview of the National Health Surveillance Agency (ANVISA).
Enjoy the article!
Update on National Implementations of IEC 60601-1:2005