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Waterfall model or v-model design and development

S

snoopy2017

#1
Hi everyone,

I have a question. For a company that develops a hardware device with software integrated into it, which development model makes sense? V-model or the waterfall model? It seems like the software development process is more agile. At one of my past companies, there was a disconnect between regulatory/quality and R&D because the former assumed a waterfall model and wrote an SOP based on that, but none of the engineers could follow that waterfall model and they ended up not following the design control SOP. Can somebody provide some guidance? That seems to be an issue I've noticed in some of the smaller medtech companies without much experience in the industry. Thanks!
 
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optomist1

A Sea of Statistics
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#2

yodon

Staff member
Super Moderator
#3
A strict waterfall method (in software especially) is a recipe for failure. As you're in the device (regulated space), though, there are certain documentation requirements (developers may want to call them burdens) that cannot be ignored. You can implement iterative methods and still fulfill the documentation requirements if you plan it properly. This link ends up being a bit of an advertisement for DOORS but has some good points about being iterative while maintaining compliance: Being agile while still being compliant

The only thing worse than waterfall would be to try to develop the documentation after the development (and test) efforts.

If you aren't already, do get familiar with IEC 62304 as it's the FDA consensus standard & EU harmonized standard for medical device software development processes.
 
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