The Emergo Group issued a White Paper on 22 October 2012 in regard to the 26 September 2012 Proposed New Medical Device Regulations for Europe (this weblink brings you to the “Medical Devices – Ongoing Revisions” page of the EUROPA website).
L. Eisner Talk 13 Dec on IEC 60601-1, 3rd ed. – US, EU, Japan, Brazil, & Canada National Implementation
Leo Eisner will be speaking on “IEC 60601–1, 3rd Edition – Where Do We Stand on National Implementation?” via FX Conferences on Dec 13, 2012 at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern). He will be discussing the National
Update Notice on IEC 60601-1:2012 Consolidated 3.1 Ed.
Update Notice #1 on IEC 60601-1:2012 Consolidated 3.1 Edition – 18 Oct 2012 On August 20, 2012 IEC released the consolidated edition 3.1 of IEC 60601-1:2012 which is a combination of IEC 60601-1:2005 (also known as 3rd ed. of IEC
Medical Devices Utilizing Tissues of Animal Origin New EU Commission Regulation
This post is on the newly published Commission Regulation (EU) No 722/2012 of 8 August 2012 “concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
IEC 60601-1:2012 Consolidated 3.1 Edition Just Published
On August 20, 2012 IEC released the consolidated edition 3.1 of IEC 60601-1:2012 which is a combination of IEC 60601-1:2005 (also known as 3rd ed. of IEC 60601-1) combined with Amendment 1:2012 (A1).