18 April 2013 – The NB-MED EN62304:2006 issues team released their first official version (V1.0) dated 5 April 2013 of this importnat implementation document in regards to EN 62304 with respect to the Medical Device Directive 93/42/EEC on the NB-MED website. EN
EU Team-NB adopted V3.0 Code of Conduct – Align to Recent Proposed Regulations
On 10 Oct 2012 The European Association for Medical devices of Notified Bodies (better known as Team-NB) issued a press release on the adoption of Version 3.0 of the Code of Conduct (CoC) for Notified Bodies under Directives 90/385/EEC (Active
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
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
MD&DI Interview Leo Eisner re:NB-MED Draft Doc EN60601 Implementation for EU
On Oct 6, 2011 MD&DI (Heather Thompson) interviewed Leo Eisner of Eisner Safety Consultants in regard to his blog posting on the NB-MED draft document “FAQ related to implementation of EN 60601-1:2006 Clarification of open issues”.