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: 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 [...]

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 [...]

On Oct 6, 2011 MD&DI (Heather Thompson) interviewed Leo Eisner of Eisner Safety Consultants in regard to his blog posting on the NB-MED draft document “FAQ related to implementation of EN 60601-1:2006 Clarification of open issues”.