The FDA’s Home Use Draft Guidance Document has drawn a lot of attention since it was published on 12 Dec 2012. The article that the Medical Electronic Device Solutions (MEDS) Trade Publication released on February 2013 is titled FDA Issues Draft
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MD&DI Articles on Home Use FDA Draft Guidance & Be Aware
This post deals with the FDA’s Draft Guidance on Home Use Devices. But it is a two for one (two articles and a note from Leo Eisner about the draft guidance to be aware of so really a 3 for
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