Changes in software

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Hello everyone! Doeas anyone knows about changes in software? We have changes in our software from time to time because...

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Posted by Melanie Beck (Discussions: 1, Comments: 0)
Replied on April 12, 2017 12:00 am
Category: Medical Devices
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In the EU world look in the applicable directive for 'when to report a change to the NB'. In the FDA world for medical devices there is a guide for 'when to report a change' and it may involve other regulations as well. Presumably the product is medical device since the posting is in this particular group. And the S/W re-design already has a risk exercise that can support the decision.
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Posted by George Butcher (Discussions: 0, Comments: 185)
Replied on April 11, 2017 8:00 pm
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    Should be new software version, new product, minor fixes same product. Not sure of situation but maybe it is a validation issue where they have validated the old software version and don't want to re-validate the new?
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    Posted by Ken Ludzack (Discussions: 0, Comments: 9)
    Replied on April 11, 2017 8:00 pm
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