Eisner Safety Consultants

Updated EN60601 Series FAQ Posted on Cenelec site in regard to the MDD & AIMD & EN60601 Series
The current document posted on 22 March 2010 is an update to the previously posted document issued 9 October 2009 on the CENELEC site

Devicemakers Given Three Years to Transition to New Standard
From  FDA News Devices & Diagnostic Letter March 29, 2010

Devicemakers may have to pay up to 40 percent more to test the safety and effectiveness of electronic devices now that CDRH has adopted an international standard for electronic devices.
Manufacturers will have three years to comply with the [...]

Eisner Safety Consultants Newsletter #5 Now Online
This issue we are going to focus on primarily on IEC/EN 60601-1:2005/2006 as there is some significant news within the last few weeks and more to come really soon.  Also, we would be remiss if we didn’t remind you that the MDD Amendment 2007/47/EC becomes mandatory this weekend on [...]

Updated EN60601 Series FAQ in regard to the MDD & AIMDDD to be posted on CENELEC website in the near future
The document is an update to the current posted document issued 9 October 2009 on the CENELEC site

Industry Update Amendment 1 of IEC 60601-1:2005 is at the 1st committee draft stage and the estimated pub date June 2012 http://ow.ly/1nuKP