On LinkedIn there is a survey posted to find out what users of the standard ISO 13485 think about revising the standard. “The purpose of this questionnaire is to determine the need for modification or updating of the ISO 13485:2003
EU Manual – Borderline Med Dvcs Ver 1.9 March 2011
The latest release of the Manual on Boderline and Classification in the Community Regulatory Framework for Medical Devices Version 1.9 was updated March of 2011. There are 4 new areas that have been incorporated into this version (1.9) of
RoHS EU Directive & the Future of Med Dvcs
Posted 12 May 2011 on the DeviceTalk blog of MD&DI, RoHS Directive and the Future of Medical Devices Thx Heather Thompson, Editor in Chief of MD&DI, for your enlightening post!
COCIR Issues Flowchart to determine if Software = Med Dvc per MDD
COCIR, the European industry association representing the radiological, electromedical and IT industries, issued (on 22 Nov 2010) a decision diagram to determine if software is considered a medical device per the Medical Device Directive (MDD) 93/42/EEC including the amendment. The
UL’s IEC 61010 3rd Ed. Int’l Activities Blog
UL has set up a blog for getting you current information on the IEC 61010-1 3rd edition is titled ‘Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements’. For the Health Care industry
