Your search resulted in 30 documents for "AAMI QUALITY SYSTEM" amongst all current AAMI documents.

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  1. MOST RECENT

    2092067

    AAMI ST72:2019▹

    Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing, Includes Erratum (2020)

    standard by Association for the Advancement of Medical Instrumentation, 11/01/2019.

    Languages: English

    Historical Editions: AAMI ST72:2011/(R)2016, AAMI ST72:2002/(R)2010

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  2. Book

    The Quality System Compendium: GMP Requirements and Industry Practice, 2nd Edition▹

    Book by Association for the Advancement of Medical Instrumentation, .

    Languages:

    Historical Editions: The Quality Systems Compendium

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  3. Book

    Medical Device Quality Systems Manual: A small entity compliance guide▹ [ Withdrawn ]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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  4. MOST RECENT

    1538805

    AAMI TIR36:2007▹ [ Withdrawn ]

    Validation of software for regulated processes

    standard by Association for the Advancement of Medical Instrumentation, 12/13/2007.

    Languages: English

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  5. Book

    Design Control Guidance for Medical Device Manufacturers▹

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

    Languages:

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  6. 1639987

    AAMI SYMBCD▹

    Medical Equipment Symbols CD - Features High Resolution Graphical Symbols and Safety Signs

    standard by Association for the Advancement of Medical Instrumentation, 2008.

    Languages:

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  7. MOST RECENT

    1922435

    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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  8. MOST RECENT

    2082207

    AAMI TIR102:2019▹

    U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems

    standard by Association for the Advancement of Medical Instrumentation, 08/30/2019.

    Languages: English

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  9. MOST RECENT

    1902084

    AAMI/ISO 11135:2014▹

    Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 07/27/2015.

    Languages: English

    Historical Editions: AAMI/ISO TIR11135-2:2008, AAMI/ISO 11135-1 / 11135-2 SET, AAMI/ISO 11135-1:2007, AAMI 11135:1994

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  10. MOST RECENT

    52566

    AAMI WQD-324▹

    Water Quality for Dialysis

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

    Languages: English

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