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
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
RoHS Recast Implications to EU Med & IVD Devices
The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: The recast of the Restriction of Hazardous Substances (RoHS) Directive has been released as 2011/65/EU. You can read the directive at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF. With the exception of
Are You Using The Proper Version of EN 60950-1?
Thank you NEMKO for this article: The standard for IT-equipment, for the EU is EN 60950-1:2006, and it was amended with A11 in 2008, with DOP (Date of Publication) 1 December 2009. The A11 is a European amendment only, with