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MD&DI Articles on Home Use FDA Draft Guidance & Be Aware
This post deals with the FDA’s Draft Guidance on Home Use Devices. But it is a two for one (two articles and a note from Leo Eisner about the draft guidance to be aware of so really a 3 for
AAMINews on IEC60601-1 Amendment 1
AAMI News: Jan 2013: Excellent Article on Amendment 1 (A1) to IEC 60601-1 Underscores Role of Safety in Device Design.
FDA on Quest to Standardize Mandatory MedDvc Labeling
On 4 Jan 2013 the FDA issued, in the Federal Register, a notice of Public Workshop entitled “Accessible Standardized Medical Device Labeling”. FDA indicated the focus of the workshop is to “discuss the growing need for medical device labeling to be