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  • 1.  Requirements management tools

    Posted 11-Dec-2023 16:28

    Hi all,

    I'm interested to know what requirements management tools medical device companies are using.

    We've been using Jama for over 10 years, and it's suited us very well for design controls, traceability, test management etc, but due to pricing and package model changes, we're currently looking to evaluate what other options are out there.

    I've heard a suggestion of Jira with R4J, Xray and Xporter plugins - does anyone have any experience with these and if they're suitable for use in the medical device space?

    What other tools do people use and like?

    thanks!

    Beth



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    Beth Gordon
    Systems Manager
    Dynamic Controls
    Christchurch
    New Zealand
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  • 2.  RE: Requirements management tools

    This message was posted by a user wishing to remain anonymous
    Posted 12-Dec-2023 09:09
    This message was posted by a user wishing to remain anonymous

    For lower-criticality and lower-complexity devices we find Word and Excel work very well. Pricing and learning curve are low.


    Original Message


  • 3.  RE: Requirements management tools

    Posted 12-Dec-2023 13:49

    You should take a look at Matrix Requirement

    https://matrixreq.com/

    cheers

    Thierry



    ------------------------------
    Thierry Houdayer
    Le Mans
    France
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    Original Message


  • 4.  RE: Requirements management tools

    Posted 19-Dec-2023 11:00

    Hi Beth,
    Something to consider is how you want your requirements tool to connect to your QMS and product such as BOMs, drawings and manufacturing documentation for Product Lifecycle Management.

    Some PLM/eQMS systems do a good job with requirements and risks but provide integrated tools that can connect to ERP and CRM systems. 

    There are several options but these are two highly rated solutions 

    https://www.arenasolutions.com

    https://www.propelsoftware.com/



    ------------------------------
    Jeff Cody
    Sr. Director, RA/QA
    MicroSurgical Technology
    Redmond WA
    United States
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    Original Message


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