It has been a bit more than 4 years since the A1 project was approved and initiated. The vote on Amendment 1 (A1) of IEC 60601-1, third edition project ended on 2 July 2012 and it was a resounding unanimous positive
Eisner Safety Consultants in Process of Updating Newsletter Delivery System
It has been over 2 years since we sent out our last newsletter. Our apologies, but the way we communicate with you has changed and so we have decided to send either monthly or weekly updates of all of our
EU Competent Authorities formed Central Management Committee (CMC) & Issued Decisions
The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther, and many thanks to NSAI the Irish Notified Body: The European Competent Authorities have formed a Central Management Committee (CMC) to achieve greater consistency in the
JIS T 0601-1:2012 Just Published (Japan’s National Version of IEC 60601-1:2005)
On June 1, 2012 Japan issued their national version of IEC 60601-1:2005 (or 3rd ed.). The transition period has started as of June 1, 2012 but I am still determining what products under Japan’s MHLW’s (Ministry of Health, Labour
Do you know how to use EN62304 (med dvc s/w life-cycle) as implemented under the EU MDD & AIMDD?
Recently it was concluded jointly by industry and European Notified Bodies that there is less clarity in the use of EN 62304 than is desirable. As a consequence, it was decided to start a project to develop a paper with