On 12 December 2012 the FDA issued a new Draft Guidance for Industry & FDA Staff on Design Considerations (for design and development) for Devices Intended for Home Use. Back in April 2010 the FDA launched the Medical Device Home
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
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
Update Notice on IEC 60601-1:2012 Consolidated 3.1 Ed.
Update Notice #1 on IEC 60601-1:2012 Consolidated 3.1 Edition – 18 Oct 2012 On August 20, 2012 IEC released the consolidated edition 3.1 of IEC 60601-1:2012 which is a combination of IEC 60601-1:2005 (also known as 3rd ed. of IEC