Recently it was concluded jointly by industry and European Notified Bodies that there is less clarity in the use of EN 62304 than is desirable. As a consequence, it was decided to start a project to develop a paper with
AAMI News Feed Added to Site
Our website has just added the News Feed from AAMI (the Association for the Advancement of Medical Instrumentation) to the left side bar on our site. This is in addition to other useful News Feeds which include AdvaMed SmartBriefs and
Update on National Implementations of IEC 60601-1:2005
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
EU medical device (MEDDEVs) guidance doc’s newly rls’ed or updated
The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: Below this article from Christine Ruther are several blog postings thx to Erik Vollegbret of Axon Lawyers but to read them you have to go
Electronic IFUs for EU MDD & AIMDD Devices
The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: The Commission Regulation of electronic instructions for use (IFUs) of Medical Devices 207/2012 was released 10 March 2012. Here’s a general summary: The directive does not cover