Do you have EU transition period questions related to the MDD & AIMDD Harmonized Standard EN IEC 60601-1:2006 (or sometimes known as 3rd edition of EN IEC 60601-1), its’ collaterals (EN IEC60601-1-XX) and its’ particulars (EN IEC 60601-2-XX) standards? If
FDA Draft Guidance – Human Factors & Usability Engineering
The FDA issued a draft guidance document on ‘Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety & Effectiveness in Design’ for Industry and FDA Staff as of June 22, 2011. A 90 day comment period is
ISO 13485 Revision – User Requirements Survey
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!