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 [...]

ESC Newsletter #2 – Just Released
This issue we are focusing on the MDD Amendment 2007/47/EC including our toolkit to make your transition much easier and an interpretative EC guidance on the implementation of 2007/47/EC.  These are both great resources to use to get you thru this transition.  Also, we will focus on EU vigilance reporting [...]

ESC Newsletter #1 – Just Released
This newsletter contains articles on IEC 60601-1, 3rd ed (published in MD&DI – Sept ‘09), The Amendment to the Medical Device Directive, Pre-Announcement of our Gap Analysis & Update Package for the MDD Amendment 2007/47/EC, our Standards & Regulations Update Service, announcement of the Medical Device Track at the Oct [...]