ISO-13485 › Complete Document History
Medical devices - Quality management systems - Requirements for regulatory purposes

Complete Current Edition:
   3RD EDITION - Requirements for regulatory purposes - March 1, 2016

Obsolete Revision Information:
   FOR 3RD EDITION FINAL DRAFT SEE - ISO/DIS-13485 - Oct. 29, 2015
   FOR 3RD EDITION DRAFT SEE - ISO/DIS-13485 - Feb. 20, 2014
   2ND EDITION CORRIGENDUM 1 - TECHNICAL CORRIGENDUM 1 FOR 2ND EDITION - Aug. 1, 2009
   2ND EDITION - Requirements for regulatory purposes - July 15, 2003
   1ST EDITION - Quality systems -- Medical devices -- Particular requirement - Dec. 15, 1996