Eisner Safety Consultants

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 [...]

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Are You Ready for MDD Amendment Directive 2007/47/EC?
Wednesday Jan 27, 2010, 2:00pm – 3:00pm Eastern Time, 60 minutes
Get a $50 discount ($199 after discount) for this event by using the special promotion code AF2009EIS when you sign up at the FX conferences website
Audio conference highlights
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ESC Newsletter #3 – Just Released
This issue we are going to focus on the 60601-1 series of standards based on the 3rd edition of 60601-1 and the MDD & AIMDD, including the Amendment 2007/47/EC for the MDD.  First we are presenting an audio conference on the Marking and Labeling requirements for IEC 60601-1 which will [...]

CENELEC FAQ’s page on the EN60601-1 Series of Standards in Relation to the MDD and AIMDD
CENELEC has issued a FAQs page on their website to clarify many of the confusing issues surrounding the EN60601 series of standards including the general (or base standard EN60601-1), the collateral standards (e.g. EN60601-1-XX), and the particular standards (e.g. EN60601-2-XX). [...]

European Device Regs To Be Recast In 2010, With Separate IVD Revision
EuroPharma Today.com article on the plans of the EU commission to overhaul the EU MDD in hopes of imposing a “modern set of rules” by 2015.