Technology Management

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  1. MOST RECENT

    AAMI TIR45:2023▹

    Guidance on the use of agile practices in the development of medical device software

    standard by Association for the Advancement of Medical Instrumentation, 03/15/2023.

    Languages: English

    Historical Editions: AAMI TIR45:2012/(R)2018

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  2. HISTORICAL

    AAMI TIR48:2015/(R)2021▹

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

    Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products [Historical]

    standard by Association for the Advancement of Medical Instrumentation, 08/14/2015.

    Languages: English

    Historical Editions: AAMI TIR48:2024

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  3. MOST RECENT

    AAMI TIR48:2024▹

    Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products

    standard by Association for the Advancement of Medical Instrumentation, 04/30/2024.

    Languages: English

    Historical Editions: AAMI TIR48:2015/(R)2021

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  4. MOST RECENT

    AAMI/IEC TIR80001-2-1:2012▹

    Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples

    standard by Association for the Advancement of Medical Instrumentation/International Electrotechnical Commission, 09/02/2012.

    Languages: English

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  5. MOST RECENT

    AAMI/IEC TIR80001-2-2:2012▹

    Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security

    standard by Association for the Advancement of Medical Instrumentation/International Electrotechnical Commission, 08/20/2012.

    Languages: English

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  6. MOST RECENT

    AAMI/IEC TIR80001-2-3:2012▹

    Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks

    standard by Association for the Advancement of Medical Instrumentation/International Electrotechnical Commission, 09/02/2012.

    Languages: English

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  7. MOST RECENT

    AAMI/IEC TIR80001-2-4:2012▹

    Application of risk management for IT-networks incorporating medical devices -- Part 2-4: General implementation guidance for healthcare delivery organizations

    standard by Association for the Advancement of Medical Instrumentation/International Electrotechnical Commission, 04/30/2013.

    Languages: English

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  8. MOST RECENT

    AAMI/IEC TIR80001-2-5:2014▹

    Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems

    standard by Association for the Advancement of Medical Instrumentation/International Electrotechnical Commission, 12/24/2014.

    Languages: English

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  9. MOST RECENT

    AAMI/IEC TIR80001-2-6:2014▹

    Application of risk management for IT-networks incorporating medical - Application guidance - Part 2-6: Guidance for responsibility agreements

    standard by Association for the Advancement of Medical Instrumentation/International Electrotechnical Commission, 08/09/2015.

    Languages: English

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  10. MOST RECENT

    AAMI/IEC TIR80001-2-7:2014▹

    Application of risk management for IT-networks incorporating medical - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

    standard by Association for the Advancement of Medical Instrumentation/International Electrotechnical Commission, 12/24/2014.

    Languages: English

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