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    Checklist Software Release

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    NISHANTH RAMAKRISHNAN (DA2252305010147)
    This document provides a checklist template for software release verification as required by IEC 62304. The checklist includes sections to verify that technical documentation such as the device description and clinical evaluation are up to date, as well as activities like software testing, risk management, and traceability have been completed. The template can be customized with additional items and embedded in a company's release workflow, such as Jira or GitHub, to document verification before releasing a new software version.

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    Checklist Software Release

    Uploaded by

    NISHANTH RAMAKRISHNAN (DA2252305010147)
    31 views3 pages
    This document provides a checklist template for software release verification as required by IEC 62304. The checklist includes sections to verify that technical documentation such as the device description and clinical evaluation are up to date, as well as activities like software testing, risk management, and traceability have been completed. The template can be customized with additional items and embedded in a company's release workflow, such as Jira or GitHub, to document verification before releasing a new software version.

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    checklist-software-release

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    This document provides a checklist template for software release verification as required by IEC 62304. The checklist includes sections to verify that technical documentation such as the device description and clinical evaluation are up to date, as well as activities like software testing, risk management, and traceability have been completed. The template can be customized with additional items and embedded in a company's release workflow, such as Jira or GitHub, to document verification before releasing a new software version.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    31 views3 pages

    Checklist Software Release

    Uploaded by

    NISHANTH RAMAKRISHNAN (DA2252305010147)
    This document provides a checklist template for software release verification as required by IEC 62304. The checklist includes sections to verify that technical documentation such as the device description and clinical evaluation are up to date, as well as activities like software testing, risk management, and traceability have been completed. The template can be customized with additional items and embedded in a company's release workflow, such as Jira or GitHub, to document verification before releasing a new software version.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 3

    Checklist: Software Release

    IEC 62304:2006
    Classes Section Document Section
    A, B, C 5.8.1 (All)
    A, B, C 5.8.2 (All)
    A, B, C 5.8.3 (All)
    A, B, C 5.8.4 (All)
    B, C 5.8.5 (All)
    B, C 5.8.6 (All)
    A, B, C 5.8.7 (All)

    Summary
    This checklist is used to verify that documentation and activities are complete before
    releasing a new version of the product.
    As with all regulatory documents, it’s more about the content than about the tool.
    You don’t have to fill this checklist out every time in Word / GDocs / etc., but
    could embed it in your Jira / GitHub workflow. The main point is that, at
    minimum, the items below should be checked (and documented) before you
    release a new version of your software.
    Feel free to add further rows in the checklist if they make sense for your company.
    This template is pretty much the bare minimum to be 62304-compliant.

    Checklist
    The following documents are up to date:
    The table below shows examples only. Add - or reference - a list of all your
    required TechDoc records.
    Item Yes No Comment
    Device
    Description
    Clinical
    Evaluation
    Declaration of
    Conformity
    (…)

    The following activities have been performed:


    Item Yes No Comment
    All relevant
    functionalities of
    the software have
    been specified; the
    Software
    Requirement List
    is complete and
    has been reviewed.
    All relevant risks
    (including risks of
    known anomalies)
    have been
    evaluated; the Risk
    Management
    Report is complete.
    Verification (as
    software system
    testing) has been
    completed.
    Design control
    traceability is
    ensured:Stakehold
    er requirements
    can be traced to
    software
    requirements.Soft
    ware requirements
    can be traced to
    system
    tests.Software
    requirements can
    be traced to
    software code
    implementation /
    software code
    reviews.Software
    requirements can
    be traced to risks
    and risk control
    measures.Stakehol
    der requirements
    can be traced to
    usability
    Item Yes No Comment
    tests.Hazard-
    related use
    scenarios can be
    traced to usability
    tests.Hazard-
    related use
    scenarios can be
    traced to risks and
    risk control
    measures.
    A version number
    as defined in the
    Software
    Development Plan
    has been assigned
    and added as a tag
    to git.
    Software is
    registered with a
    Notified Body.
    If release includes
    substantial change:
    Notified Body has
    been informed.
    Label is applied
    correctly including
    CE marking.

    Template Copyright openregulatory.com. See template license.


    Please don’t remove this notice even if you’ve modified contents of this template.

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