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 ’09 IEEE Product Safety Engineering Society, and on the launch of Eisner Safety Consultants New Website.

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On October 27, 2009, Leo Eisner, of Eisner Safety Consultants and the Chair of the Medical Track for this Symposium, will be presenting a regulatory update on IEC 60601-1, 3rd edition at the 2009 IEEE Symposium on Product Safety Engineering Society. This presentation will be part of a whole day medical track which will include speakers from the FDA, IEC TC 210 Convener (ISO 14971), experts on the IEC 60601-1, human factors, etc. and will have two panel discussions as well.