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 Download all our newsletters at http://www.EisnerSafety.com/esc-news/

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. [...]

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 [...]

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 [...]

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 [...]