Eisner Safety Consultants

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 our own News Feed powered by MedIntelliBase.  All 3 of these News Feed services, which [...]

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 [...]

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 to the bottom of this posting. Several European medical device guidance documents (MEDDEVs) have been [...]

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 IVDD devices which have their own guidance document. In general, an e-IFU is allowed for: [...]

Today (22 MARCH 2012) Health Canada (HC) has issued to manufacturer’s of record (those mfr’s with a HC License to sell & market product in Canada) a NOTICE titled “ADDITIONAL GUIDANCE ON TRANSITION FROM THE SECOND TO THE THIRD EDITIONS OF THE IEC 60601 FAMILY OF STANDARDS ON HEALTH CANADA’S LIST OF RECOGNIZED STANDARDS.”  HC has [...]