26 Oct 2010 From ‘MTB europe – Technology for healthcare’ Eucomed calls for improvements in EU Notified Body based system http://www.mtbeurope.info/news/2010/1010051.htm
IEC 62A/726/NP Collateral IEC 60601-1-XX Emergency Med Srvcs Circulated for Vote
The New Work Proposal IEC 62A/726/NP and ISO TC121 SC3 N1534 was circulated on 5-Nov-2010 within IEC TC 62 (Technical Committee on Electrical Equipment in Medical Practice) and its’ subcommittees 62A – 62D, as well as ISO TC 121 (Tech
IEC 62502 1st ed. Event Tree Analysis (ETA) Techniques
Just published Oct 27, 2010 – IEC 62502 1st edition – “Analysis techniques for dependability – Event tree analysis (ETA)” The scope of the standard states:
IEC 80001-1 1st ed Application of Risk Mgmt for IT Networks Incorporating Med Dvcs
IEC 80001-1 edition 1 was published Oct 27, 2010 and is for the “Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities” The scope states, noting that all ALL CAPITAL words are defined
AUS & CAN Sign MoU Recognition Mfr’s QS
On Oct 22, 2010 the TGA posted on their website the following info: “The Therapeutic Goods Administration (TGA) and Health Canada (HC) are pleased to announce that the Memorandum of Understanding (MoU) on reciprocal recognition of quality management system (QMS)