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    The document outlines the key stages in the lifecycle of medical devices including concept definition, detailed design, production preparation, product release, post-production, and end of life. It notes several important standards used at each stage including ISO 14971 for risk management planning, ISO 60601 for safety standards, ISO 15223 for labeling, and ISO 13485 for quality management systems. The full lifecycle is managed through parallel processes for requirements engineering, software development, usability engineering, and risk management.

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    Use of Safety and Process Standards in the Lifecycle of Medical Devices - Initial Conceptual Dra

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    The document outlines the key stages in the lifecycle of medical devices including concept definition, detailed design, production preparation, product release, post-production, and end of life. It notes several important standards used at each stage including ISO 14971 for risk management planning, ISO 60601 for safety standards, ISO 15223 for labeling, and ISO 13485 for quality management systems. The full lifecycle is managed through parallel processes for requirements engineering, software development, usability engineering, and risk management.

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    © All Rights Reserved
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    12 views1 page

    Use of Safety and Process Standards in The Lifecycle of Medical Devices - Initial Conceptual Dra

    Uploaded by

    normal
    The document outlines the key stages in the lifecycle of medical devices including concept definition, detailed design, production preparation, product release, post-production, and end of life. It notes several important standards used at each stage including ISO 14971 for risk management planning, ISO 60601 for safety standards, ISO 15223 for labeling, and ISO 13485 for quality management systems. The full lifecycle is managed through parallel processes for requirements engineering, software development, usability engineering, and risk management.

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    © All Rights Reserved
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    Use of safety and process standards in the lifecycle of medical devices

    – initial draft – Marcelo Antunes – April 12, 2010


    Device
    requirements
    Concept Risk
    (functional,
    definition management of Post-market
    safety, usability,
    Team definition the production surveillance
    reliability, other)
    process

    Cronograma de
    atividades

    Informational
    Need / Project design / Production
    Detailed design Product release Post-production End of life
    opportunity planning conceptual preparation
    design
    Product development
    planning, including Selection of
    risk management standard (ISO/
    planning (ISSO TR 16142)
    Technical
    14971) and software Regulatory
    solutions to Adverse events
    development approval
    device design (ISO 19218)
    planning (IEC 62304)
    (and risk control
    of hazardous
    situations (can
    be based for
    Development of example on info Process Nomenclature
    regulatory of safety validation (ISO 15225)
    strategy standards such
    as IEC 60601))
    Risk
    Labeling (ISO
    management
    15223)
    feedback

    Initial risk Verification (can


    analysis include tests of
    (outside the safety standards)
    scope of ISO CAPA
    14971)
    Validation including
    Financial,
    clinical evaluation
    market, other
    (can include clinical
    analysis, etc.
    investigation, ISO
    14155)
    Parallel processes

    Risk management process (ISO 14971) Requirements engineering process Software development process (IEC 62304) and software risk
    Quality management system (ISO 13485) Usability engineering process (IEC 62366) management process (IEC/TR 80002-1)

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