(Note this service is not offered anymore please contact us with your questions.) Do you make Medical Electrical Equipment & Systems (MEE&S) or Home Use MEE&S? Are you up to date on all the applicable Current & Draft Medical Electrical
What is the Scope of IEC 60601-1:2005 (3rd edition)?
This blog will help you determine if and how the IEC 60601-1 Standard applies to your medical electrical product. Definitions, third-party testing, etc. discussed. One of the first questions clients ask before a project starts is, “Does this medical electrical product fall
FDA Extends AAMI ES 60601-1 Transition Date to 31 Dec ’13 & Other Important Changes – Recognition Lists 031/032
The big news in the IEC 60601-1, 3rd ed. world today is the US National Standard that is in the FDA’s Recognized Consensus Standards Lists [Now is ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) – Recognition List #:
IEC 60601-1, 3rd ed. related standards changes & new Interpretation Sheet 3
IEC 60601-1, 3rd ed. has been out for about 7 years now and there have been lots of changes within the IEC 60601 series of standards to align with 3rd edition.
Presentation on Navigating FDA’s Home Use Medical Devices Draft Guidance
Leo Eisner will be presenting on the topic “Navigating FDA’s Draft Guidance on Home Use Medical Devices” at an FX Conferences event on 11 July, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern). You don’t have to