Eisner Safety Consultants: Qmed Qualified Supplier

IMDRF Draft Guidance Doc’s Out for Comment: UDI & 3rd Party Audits

The  International Medical Device Regulators Forum (IMDRF) has been really busy of late, which is a good thing as many in the medical device industry are still wondering if the IMDRF will live up to the “Big Shoes” that the GHTF left behind when it was decommissioned in the last. In another post I will […]

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 […]

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 the GHTF’s” 20 years and the aim is to “accelerate international medical device regulatory harmonization […]

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.

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 60601-1) combined with Amendment 1:2012 (A1).