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  • 1.  European standard that allows a medical software development in Agile methodology

    Posted 27-Jun-2021 10:39
    Hey Everyone
    Anyone familiar with an European standard that allows a medical software development in Agile methodology? Equivalent to TIR-45 for FDA
    Thanks
    Ella

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    Ella Sheiman
    Haifa
    Israel
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  • 2.  RE: European standard that allows a medical software development in Agile methodology

    Posted 27-Jun-2021 23:53
    Hello

    For EU, it's generally expected​ to follow 62304, which doesn't distinguish between agile and other methodologies. There's no reason you couldn't define an agile process aligned with 62304, with or without reference to TIR45.

    By now there are so many companies incorporating some agile aspects, I would hope it wouldn't be unfamiliar to the NB reviewer.

    I don't know of any EN specifically addressing agile concepts.

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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: European standard that allows a medical software development in Agile methodology

    Posted 28-Jun-2021 03:00
    Thank you very much for the detailed answer!

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    Ella Sheiman
    Haifa
    Israel
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    Original Message


  • 4.  RE: European standard that allows a medical software development in Agile methodology

    Posted 28-Jun-2021 10:27
    Hi Ella,

    There is no Europe guidance or other standard describing Agile, such as AAMI TIR 45 does.  The most related is indeed IEC 62304 but does may not about this methodology in a way expected.  I did hear the standard's next version was supposed to have some additional information about Agile.  The closest you will probably find for Europe is various white papers or presentations from individuals/companies for how to apply an Agile/rapid deployment in an IEC 62304 lifecycle approach.  IEC 62304 can be used, just have to think of many little cycles circular in nature than a more bigger, longer circle approach in the standard.  There are some people on the committee for IEC 62304 maybe who could shed some light because I understand there was a draft 2021 version circulating which was rejected (something about risk management and ISO 14971).  It is sad really because the main standard for software lifecycle in medical devices has not been updated in over 5 years which is about 100 years in software time !

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: European standard that allows a medical software development in Agile methodology

    Posted 29-Jun-2021 01:26
    Thank you very much!!!

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    Ella Sheiman
    Haifa
    Israel
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    Original Message


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