FDA update November 1, 2011:Revision of ISO 13485

Revision of ISO 13485

Dear Medical Device Registered Establishment,

The International Organization for Standards (ISO) Technical Committee (TC) 210 is re-opening the survey on "Revisions to ISO 13485" for an additional three months in order to obtain additional industry input. 

  • The results of the initial survey were reviewed in a meeting of the TC in Alexandria last week and the Working Group would like to solicit additional input in order to represent many different medical device manufacturers, as well as manufacturers from all around the world.  The survey will remain open until January 23, 2012. 
  • The results of the survey will be utilized to develop the design specifications for the revision of ISO 13485 at its next meeting in March 2012.
  • The revision of ISO 13485 is projected to be completed in 2015 and may have substantial impact on medical device manufacturers around the world.  Medical device manufacturers and medical device associations are highly encourage to participate in this process both through the survey and other commenting opportunities. 

Anyone wishing to join TC 210 Working Group 1, who was assigned this new work item, should contact Hillary Woehrle, Director, Standards - AAMI - Association for the Advancement of Medical Instrumentation at HWoehrle@aami.org   Phone  +1-703-253-8293 or Fax +1-703-276-0793.

Or you can send your Reviews before January 23, 2012 at info@mdiconsultants.comand REF: Revision ISO 13485