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Document History for ISO 13485

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ISO 13485 3rd Edition, March 1, 2016
Complete Document
Medical devices - Quality management systems - Requirements for regulatory purposes

ISO 13485

3rd Edition, March 1, 2016

Complete Document
 
Medical devices - Quality management systems - Requirements for regulatory purposes
Active, Most Current
EN
Additional Comments:
ENGLISH
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PDF   : $185.00
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ISO 13485 2nd Edition, July 15, 2003
Complete Document
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ALSO CHECK OUT ISO 13485 PRACTICAL GUIDE AND ISO 13485 CHECKLIST)
Includes all amendments and changes through Corrigendum 1, August 1, 2009

ISO 13485

2nd Edition, July 15, 2003

Complete Document
 
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ALSO CHECK OUT ISO 13485 PRACTICAL GUIDE AND ISO 13485 CHECKLIST)
Includes all amendments and changes through Corrigendum 1, August 1, 2009
Additional Comments:
ENGLISH
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PDF   : $82.00
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ISO 13485 Corrigendum 1, August 1, 2009
Corrigendum 1 Only
Medical devices — Quality management systems — Requirements for regulatory purposes TECHNICAL CORRIGENDUM 1

ISO 13485

Corrigendum 1, August 1, 2009

Corrigendum 1 Only
 
Medical devices — Quality management systems — Requirements for regulatory purposes TECHNICAL CORRIGENDUM 1
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ENGLISH
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PDF   : $40.00
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ISO 13485 2nd Edition, July 15, 2003
Base Document Only
Medical devices - Quality management systems - Requirements for regulatory purposes
Includes all amendments and changes through Change/Amendment , July 15, 2003

ISO 13485

2nd Edition, July 15, 2003

Base Document
 
Medical devices - Quality management systems - Requirements for regulatory purposes
Includes all amendments and changes through Change/Amendment , July 15, 2003
Additional Comments:
ENGLISH
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PDF   : $82.00
Print   : $82.00
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ISO 13485 1st Edition, December 15, 1996
Complete Document
Quality Systems - Medical Devices - Particular Requirements for the Application of ISO 9001

ISO 13485

1st Edition, December 15, 1996

Complete Document
 
Quality Systems - Medical Devices - Particular Requirements for the Application of ISO 9001
Additional Comments:
ENGLISH
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PDF   : $82.00
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