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