Eisner Safety Consultants

Do you have EU transition period questions related to the MDD & AIMDD Harmonized Standard EN IEC 60601-1:2006 (or sometimes known as 3rd edition of EN IEC 60601-1), its’ collaterals (EN IEC60601-1-XX) and its’ particulars (EN IEC 60601-2-XX) standards?  If you do, you have until June 30th, 2011 to submit your questions to an expert [...]

COCIR, the European industry association representing the radiological, electromedical and IT industries, issued (on 22 Nov 2010) a decision diagram to determine if software is considered a medical device per the Medical Device Directive (MDD) 93/42/EEC including the amendment.  The document includes a clear definition of what software includes, which is a wide range of [...]

This article is courtesy from BSI Healthcare eUpdate of 11-APR-2011.  We send out thanks to BSI for such an informative and critical article for the medical device and IVD industries selling product in Europe (EU). Medical device manufacturers should be aware that it is not only the medical devices directives that are currently being considered [...]

Come join Eisner Safety Consultants at one or both conferences March 3 & 4th.  Both are related to the 60601 series of standards. On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully).  More information [...]

The latest update to the Harmonized List of Standards under the medical device directive (MDD) 93/42/EEC was issued on 18-JAN-11