GMP/Quality Systems

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  1. HISTORICAL

    AAMI/ISO 13485:2003/(R)2009▹

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

    Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 06/18/2003.

    Languages: English

    Historical Editions: AAMI/ISO 13485:2016/(R)2019, AAMI/ISO 13485:1996

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  2. MOST RECENT

    AAMI/ISO 13485:2016/(R)2019▹

    Medical devices - Quality management systems - Requirements for regulatory purposes

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 03/25/2016.

    Languages: English

    Historical Editions: AAMI/ISO 13485:2003/(R)2009, AAMI/ISO 13485:1996

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  3. AAMI CE-293▹

    The CE Mark: Understanding the Medical Device Directive

    Handbook / Manual / Guide by Association for the Advancement of Medical Instrumentation, 01/01/1997.

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  4. Design Control Guidance for Medical Device Manufacturers▹

    Book by Association for the Advancement of Medical Instrumentation, 03/11/1997.

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  5. AAMI GMP1.5▹

    GMP Manual 5th edition - Complying with FDA Good Manufacturing Practice requirements: How to develop your Quality Systems Manual

    Handbook / Manual / Guide by Association for the Advancement of Medical Instrumentation, 02/01/1997.

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  6. MOST RECENT

    Current Issues in Medical Device Quality Systems▹

    Book by Association for the Advancement of Medical Instrumentation, 11/01/1996.

    Languages: English

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  7. HISTORICAL

    The Quality Systems Compendium▹

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

    Book by Association for the Advancement of Medical Instrumentation, 05/01/1998.

    Languages:

    Historical Editions: The Quality System Compendium: CGMP Requirements and Industry Practice, Fourth Edition, The Quality System Compendium: CGMP Requirements and Industry Practice, Third Edition, The Quality System Compendium: GMP Requirements and Industry Practice, 2nd Edition

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  8. Do it by design: An introduction to human factors in medical devices▹

    Book by Association for the Advancement of Medical Instrumentation, 12/01/1996.

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  9. The Medical Device Directives: A Manufacturers' Handbook▹

    Book by Association for the Advancement of Medical Instrumentation, 08/01/1996.

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  10. Medical Device Quality Systems Manual: A small entity compliance guide▹ [ Withdrawn ]

    Book by Association for the Advancement of Medical Instrumentation, 03/01/1997.

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