COCIR, the European industry association representing the radiological, electromedical and IT industries, issued (on 22 Nov 2010) a decision diagram to determine if software is considered a medical device per the Medical Device Directive (MDD) 93/42/EEC including the amendment. The
UL’s IEC 61010 3rd Ed. Int’l Activities Blog
UL has set up a blog for getting you current information on the IEC 61010-1 3rd edition is titled ‘Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements’. For the Health Care industry
Recasted RoHS Directive will apply to Med Dvcs & IVDs
This article is courtesy from BSI Healthcare eUpdate of 11-APR-2011. We send out thanks to BSI for such an informative and critical article for the medical device and IVD industries selling product in Europe (EU). Medical device manufacturers should be
Two Conf’s on 60601 Series of Stds Mar 3 & 4th
Come join Eisner Safety Consultants at one or both conferences March 3 & 4th. Both are related to the 60601 series of standards. On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and
AAMI FDA Int’l Conf on Med Dvc Stds & Regulation MAR 23-24, ’11
The 21st Annual AAMI/FDA International Conference on Medical Device Standards & Regulation, is on March 23 – 24, 2011 at the Hyatt Dulles Hotel in Herndon, VA. Leading standards experts discuss these issues http://ht.ly/43C6V