TC 210: Quality management and corresponding general aspects for medical devices

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  1. HISTORICAL

    ISO 13485:2003

    This document has been replaced. View the most recent version.

    Medical devices - Quality management systems - Requirements for regulatory purposes

    standard by International Organization for Standardization, 07/15/2003.

    Languages: English

    Corrigenda: ISO 13485/Cor1:2009

    Historical Editions: ISO 13485:2016 Plus RedlineISO 13485:2016ISO/TR 14969:2004ISO 13485 AND 14969 PACKAGEISO 13485:1996

  2. MOST RECENT

    ISO 13485:2016

    Medical devices - Quality management systems - Requirements for regulatory purposes

    standard by International Organization for Standardization, 03/01/2016.

    Languages: English

    Historical Editions: ISO 13485:2016 Plus RedlineISO/TR 14969:2004ISO 13485 AND 14969 PACKAGEISO 13485:2003ISO 13485:1996

  3. HISTORICAL

    ISO 13485:2016

    This document has been replaced. View the most recent version.

    Medical devices - A Practical Guide

    standard by International Organization for Standardization, 11/01/2016.

    Languages: English

    Historical Editions: ISO 13485:2016ISO 13485:2016 - Medical Devices - A Practical Guide

  4. HISTORICAL

    ISO 13485:2016 - Medical Devices - A Practical Guide

    This document has been replaced. View the most recent version.

    Medical devices - A practical guide

    standard by International Organization for Standardization, 07/01/2016.

    Languages: English

    Historical Editions: ISO 13485:2016ISO 13485:2016

  5. HISTORICAL

    ISO 13485:2016 Plus Redline

    This document has been replaced. View the most recent version.

    Medical devices - Quality management systems - Requirements for regulatory purposes (includes Redline Version)

    standard by International Organization for Standardization, 11/01/2016.

    Languages: English

    Historical Editions: ISO 13485:2016ISO/TR 14969:2004ISO 13485 AND 14969 PACKAGEISO 13485:2003ISO 13485:1996

  6. MOST RECENT

    ISO 13485/Cor1:2009

    Medical devices - Quality management systems - Requirements for regulatory purposes - Corrigendum 1

    Corrigenda by International Organization for Standardization, 08/01/2009.

    Languages: English

    Priced From:

  7. HISTORICAL

    ISO/TR 14969:2004 [ Withdrawn ]

    This document has been replaced. View the most recent version.

    Medical devices - Quality mangement systems - Guidance on the application of ISO 13485:2003

    standard by International Organization for Standardization (Technical Report), 10/15/2004.

    Languages: English

    Historical Editions: ISO 13485:2016 Plus RedlineISO 13485:2016ISO 13485 AND 14969 PACKAGEISO 13485:2003ISO 13485:1996

  8. HISTORICAL

    ISO 14971:2007

    This document has been replaced. View the most recent version.

    Medical devices - Application of risk management to medical devices

    standard by International Organization for Standardization, 10/01/2007.

    Languages: English

    Historical Editions: ISO 14971:2019 Plus RedlineISO 14971:2019ISO 14971/Amd1:2003ISO 14971:2000

  9. MOST RECENT

    ISO 14971:2019

    Medical devices - Application of risk management to medical devices

    standard by International Organization for Standardization, 12/01/2019 in Spanish, English.

    Languages: English,Spanish

    Historical Editions: ISO 14971:2019 Plus RedlineISO 14971:2007ISO 14971/Amd1:2003ISO 14971:2000

  10. HISTORICAL

    ISO 14971:2019 Plus Redline

    This document has been replaced. View the most recent version.

    Medical devices - Application of risk management to medical devices

    standard by International Organization for Standardization, 12/01/2019.

    Languages: English

    Historical Editions: ISO 14971:2019ISO 14971:2007ISO 14971/Amd1:2003ISO 14971:2000