ESC added a #Medical Device Industry & #Regulatory Newsfeed to all pages of our website on the left hand sidebar. Thx to MedInteliBase
FDA CDRH Last of 3 Town Hall Discussions Oct 7, ’10 in Irvine, CA
FDA CDRH Last of 3 Town Hall Discussions Irvine, CA – Director of CDRH & Senior Staff, October 7, 2010 http://ht.ly/2aT7X
Eisner Safety Consultants Newsletter #6 Now Online
Eisner Safety Consultants Newsletter #6 – published 6/30/2010 & covers Recent news on IEC/EN 60601-1:2005/2006; Classification MedDev, Clinical Data & Usability Analysis Requirements per the Amended MDD; and Rechargeable Batteries with Inductive Coupling Download all our newsletters at http://www.EisnerSafety.com/esc-news/
NAMSA offering seminars – Biocompatibility of Med. Dvcs Aug – Oct, ’10
NAMSA is offering seminars on Biocompatibility of Medical Devices in Massachusetts, Minnesota & Singapore Aug thru Oct, 2010 http://ht.ly/25q39
FDA Formally Recognized AAMI ES60601-1:2005 as Consensus Std 6/10/10
FDA Formally Recognized AAMI ES60601-1:2005 (National Version of IEC60601-1:2005 = 3rd edition) as Consensus Standard on 6/10/10. The transition period indicated on the FDA Consensus Standard web page for AAMI/ANSI ES 60601-1:2005 says in summary that 2nd edition of IEC