I would like to let all of you know of two experts that have joined the Eisner Safety Consultants team recently which will help us support a growing need for IEC 60601-1, 3rd edition and edition 3.1 projects that we
CAN/CSA C22.2 No. 60601 Standard Changes
Reminder post – withdrawal of CAN/CSA C22.2 No. 601.1-M90+A1+A2 is on June 30, 2014 & CAN/CSA-C22.2 No. 60601-1:14 was recently published
EN60601-1:2006 + A1:2013 Has Been Harmonized Under the MDD
This post discusses that EN60601-1:2006+Amendment 1 (A1):2013 has finally been Harmonized under the MDD. This is really big news that many of us in the medical industry have been waiting to hear occur for quite awhile. What’s The Big News
BSI Update on ISO 13485:201X – 3rd Revision
This posts discusses BSI’s article on the status of the draft ISO 13485:201X standard. Recently BSI published an e-newsletter and in it was an excellent article explaining the status of the next draft revision of ISO 13485 and some of
Status Update on NBRG Risk Management Consensus Document
This post is a status update on the NBRG RMWG Risk Management Consensus Document 30 April 2014 – The NBRG (Notified Body Recommendation Group) Risk Management Working Group (RMWG) membership will have a face to face meeting in mid May to