Eisner Safety Consultants

The new MHRA website home page is now live and you are being sent to the Home Page of the newly revamped site! The UK MHRA has updated their website to be much more functional and you can find a lot of information about the Directives (i.e. MDD, IVD, & AIMDD) related to the medical [...]

16 Jan 2012 Just received an e-mail update on the status of the DRAFT NB-MED document on 3rd edition of EN60601 Implementation for the EU. The pertinent points are: 1) Substantial progress has been made over the last couple months on the document 2) The NB-MED has presented their observations and comments on the proposed [...]

On Oct 6, 2011 MD&DI (Heather Thompson) interviewed Leo Eisner of Eisner Safety Consultants in regard to his blog posting on the NB-MED draft document “FAQ related to implementation of EN 60601-1:2006 Clarification of open issues”.

This article is an update to the June 24, 2011 article “EU EN IEC 60601-1 3rd ed. Request for Issues on the use of the Std for CE-Conformity” On October 1, 2011 the DRAFT “FAQ related to Implementation of EN 60601-1:2006 Clarification of open issues” was issued and this DRAFT document is being sent to [...]

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 [...]