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Agile Software Development and 510(k) Submission

Z

zmimshen

#1
Hi all,
As a consultant I have done many 510(k) submissions and many of them contained software. In all of the previous submissions I received from the companies the regular software documentation, i.e., SRS, SDS, tractability etc.
I have recently cam across a company that needs to submit a 510(k) for their software device however they are using agile development and therefore all the required software documents per FDA guidance are lacking.
Does anyone have experience with submitting a 510(k) for a software device that has been developed in such a way?
What exactly do we submit to FDA and was the process successful?
 
Elsmar Forum Sponsor

sagai

Quite Involved in Discussions
#3
Actually I think only few company can afford not to put in place a kind of agile method for software development.
I doubt if there is any purely waterfall kind of development exists at all in reality.

Agile is not about not having documentation, it clearly a kind of misinterpretation of the manifesto saying
Working software over comprehensive documentation
In addition to that, how does it possible to ensure any level of maintainability for a development not producing any measurable control and history over the design apart from the source code?

Having said that, I think your client was desperately misinterpreted agile whilst not producing any documentation as regard to the design.

My guess is that unconsciously there should be the majority of the information needed in their historical backlog, but there is a chance that there is no segregation between tasks, requirements, tests, etc. and traceability among those items in the backlog.

If you look into the system they may use to manage their activities, I think you find your answer.

Cheers!


Ps.: Actually there is a guidance for companies facing with this challenge from AAMI.
Here is the link:
http://marketplace.aami.org/eseries/scriptcontent/docs/Preview Files/TIR45_1208_preview.pdf

I am not saying I am fully happy with its content, it provides a good insight what perspectives need to be considered.
Any company can work out its own way and they have to instead of enforcing a canned solution.
 
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