This posts discusses BSI’s article on the status of the draft ISO 13485:201X standard. Recently BSI published an e-newsletter and in it was an excellent article explaining the status of the next draft revision of ISO 13485 and some of
Medical Device Audit Training Opportunities
Rob Packard & Brigid Glass have a couple opportunities for you to learn about different aspects of medical device auditing. These offerings are in February & April 2013 and range from a 1 hour audio conference, to a free webinar,
GHTF has transitioned to IMDRF
As of November 2012 the GHTF (Global Harmonization Task Force) is no longer operating as evidenced by several pieces of information. In it’s place the International Medical Device Regulators Forum (IMDRF) is working to “build on the strong foundation of
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