Information for this posting has been provided by a 29 November 2012 communique titled “Trans Tasman Ministerial Council progresses joint therapeutic products scheme” from the Australian Government – Parliamentary Secretary for Health and Ageing and Parliamentary Secretary for Infrastructure and
When will IEC 60601-1:05+A1:12 turn into EN Standard?
In the LinkedIn Group – BSI Standards Network – there was this question on 6 Nov ’12: “Does anyone in the group know when the IEC 60601-1-1:2005 +A1:2012 is likely to get turned into a EN by Cenelec?”
GHTF has transitioned to IMDRF
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
Eisner Safety Consultants Newsletter #6 Now Online
Eisner Safety Consultants Newsletter #6 – published 6/30/2010 & covers Recent news on IEC/EN 60601-1:2005/2006; Classification MedDev, Clinical Data & Usability Analysis Requirements per the Amended MDD; and Rechargeable Batteries with Inductive Coupling Download all our newsletters at http://www.EisnerSafety.com/esc-news/