As of November 2012 the GHTF (Global Harmonization Task Force) is no longer operating as evidenced by several pieces of information. In it’s place the International Medical Device Regulators Forum (IMDRF) is working to “build on the strong foundation 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
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
Tracking Vital Signs, Without the Wires
In the New York Times on Sept 3, 2011 – The article starts ‘CONFINED to their hospital beds, patients can only fantasize about stripping off all the wires that connect them to monitors and bolting for the door…’
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