Eisner Safety Consultants: Qmed Qualified Supplier

New LinkedIn Group on IEC 60601 Medical Electrical Equipment & Systems

A new LinkedIn group has been formed thx to the support of the IEC (International Electrotechnical Commission)*.  The group name is the IEC 60601 series of standards on Medical Electrical Equipment.  This group is not just about the 3rd edition of IEC 60601-1 but about the whole series of IEC 60601 series of standards and […]

L. Eisner Talk 13 Dec on IEC 60601-1, 3rd ed. – US, EU, Japan, Brazil, & Canada National Implementation

Leo Eisner will be speaking on “IEC 60601–1, 3rd Edition – Where Do We Stand on National Implementation?” via FX Conferences on Dec 13, 2012 at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern).  He will be discussing the National Implementation for the US, EU, Japan, Brazil, & Canada.

Health Canada’s Guidance – Transition fr 2nd to 3rd ed. of IEC 60601-1 & related 60601 Series of Stds

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 […]

NB-MED issues V1.1 FAQ on Implementation of EN60601-1:2006 w.r.t. MDD

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 […]

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 the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully).  More information […]