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  • AAMI TIR45 : 2012

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE

    Available format(s):  Hardcopy, PDF

    Superseded date:  23-07-2013

    Language(s):  English

    Published date:  01-01-2012

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    Glossary of equivalent standards
    Committee representation
    Foreword
    Introduction
    Why read this TIR?
    Initial recommendations
    1 Scope
    2 References
    3 Terms and definitions
    4 Setting the stage
    5 Aligning on concepts
    6 Aligning on Practices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies perspectives on the application of AGILE during medical device software development.

    General Product Information - (Show below) - (Hide below)

    Committee SW
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
    IEEE 828-2012 IEEE Standard for Configuration Management in Systems and Software Engineering
    ISO/IEC 20926:2009 Software and systems engineering — Software measurement — IFPUG functional size measurement method 2009
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    ISO/IEC/IEEE 24765:2017 Systems and software engineering — Vocabulary
    ISO/IEC 20000-1:2011 Information technology Service management Part 1: Service management system requirements
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    AAMI IEC 62304 : 2006 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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