This post will help you understand some of the steps you should start taking immediately to implement your new ISO 13485:2016 QMS. Updated with additional info on 29 February 2016 and 5 April 2016 (Update is italicized) Are you ready
greenlight.guru Partners with Eisner Safety Consultants
We strive at Eisner Safety Consultants (ESC) to provide the best services for our clients and we have found one that is ideal for many of our small to mid size medical device companies we work with. greenlight.guru produces
BSI Update on ISO 13485:201X – 3rd Revision
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
GHTF Just Released New & Updated Documents
The Global Harmonization Task Force (GHTF) recently had a meeting and with that came a slew of final documents that were issued on 2 Nov 2012.