A very useful document was recently released to be a summary of the significant and moderate changes made to IEC 60601-1:2005 based on Amendment 1 (A1) of IEC 60601-1. This is an excellent resource (IEC TR 62348:2012, published 12 Dec
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
MD&DI Articles on Home Use FDA Draft Guidance & Be Aware
This post deals with the FDA’s Draft Guidance on Home Use Devices. But it is a two for one (two articles and a note from Leo Eisner about the draft guidance to be aware of so really a 3 for
FDA Issues Draft Guidance on MedDvcs Intended for Home Use
On 12 December 2012 the FDA issued a new Draft Guidance for Industry & FDA Staff on Design Considerations (for design and development) for Devices Intended for Home Use.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
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