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Software development plan for SW update


Starting to get Involved
Hello everyone,

I would like to know if to be compliant with 62304, we need to produce a SW development plan for each software update or can we use one development plan for the whole life of the product and reference a kind of roadmap document for the planning that will provides the planning and dates of activities for each update?

Since we're planning to have regular updates of our mobile app, I would like to reduce the unecessary paperwork.


Involved In Discussions
The SW development plan is simply the umbrella that outlines how you address the requirements of the SW development process. For example, I use a compliance matrix that outlines where the 62304 requirements are addressed in the various procedures we have as part of our quality Management System, and those procedures go into the details of how the requirements are addressed. So think of this is as the overall framework which includes how you deal with, for example, SW changes including change requests and verification results. Those specific items (i.e. change requests and verification results, as examples) are the ones you need to have per each SW releases but the plan itself should remain as is.

Hope this helps.
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