Eisner Safety Consultants

Eisner Safety Consultants Newsletter #6 – published 6/30/2010 & covers Recent news on IEC/EN 60601-1:2005/2006; Classification MedDev, Clinical Data & Usability Analysis Requirements per the Amended MDD; and Rechargeable Batteries with Inductive Coupling

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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 [...]

In the April 2009 edition of our medical information flyer ‘Transition to EC Directive 2007/47/EC’, we informed you that we assumed, in view of the status of discussions at that time, that new declarations of conformity would have to be issued.
In our newsletter of 2 July 2009 we revised this statement and explained that not [...]

Time is running out to meet the MDD Amendment 2007/47/EC (Mar 21) see http://www.EisnerSafety.com/products/ for great resource at $249

Eisner Safety Consultants Newsletter #4 Available on the web
This issue we are going to focus on primarily on the MDD Amendment 2007/47/EC as the deadline to comply is very soon.  You must comply with the MDD Amendment 2007/47/EC as of March 21, 2010.  There is no transition period for the amendment to the MDD.  First, [...]