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  • AAMI SW87 : 2012

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    APPLICATION OF QUALITY MANAGEMENT SYSTEM CONCEPTS TO MEDICAL DEVICE DATA SYSTEMS

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  15-04-2018

    Language(s):  English

    Published date:  31-12-2011

    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
    1 Introduction
    2 Quality management system
    3 Glossary
    4 Acronyms
    5 References

    Abstract - (Show below) - (Hide below)

    Specifies the importance of and provides guidance on the implementation of quality management systems to the design, development, provision, and support of medical device data systems as defined by the U.S. Food and Drug Administration (FDA).

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

    Committee WG 01
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Withdrawn

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

    IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
    IEC TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
    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/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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