Eisner Safety Consultants

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: [...]

6 Feb 2012 – The NB-MED EN60601-1:2006 issues team released their first official version (V1.1) of this important implementation document in regards to EN 60601-1 with respect to the Medical Device Directive 93/42/EEC (primarily written for this directive) and also the Active Implantable Medical Device Directive 90/385/EC (refer to Q & A 3.3.1).  This project [...]

The new MHRA website home page is now live and you are being sent to the Home Page of the newly revamped site! The UK MHRA has updated their website to be much more functional and you can find a lot of information about the Directives (i.e. MDD, IVD, & AIMDD) related to the medical [...]