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 Team-NB adopted V3.0 Code of Conduct – Align to Recent Proposed Regulations
On 10 Oct 2012 The European Association for Medical devices of Notified Bodies (better known as Team-NB) issued a press release on the adoption of Version 3.0 of the Code of Conduct (CoC) for Notified Bodies under Directives 90/385/EEC (Active
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
Amendment 1 of IEC 60601-1:05 (3rd edition) has been published by IEC
On 13 July 2012 IEC formally published the long awaited IEC 60601-1:05 (also known as third edition) Amendment 1 (A1). It is available on the IEC.ch website’s store. Refer to my previous post of 11 July announcing the imminent release
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