IEC 62304 software costs and time

#1
Hello everyone,

we are developing a software (SW) which will be likely be classified as class B SW.

Does anyone know how much money it will approximately cost to conduct the tests as per IEC 62304 requirements? And approx how much time it can take?

We are a small company just developing our first SW and this will be really really helpful to us.

Highly appreciate it!!!
Thank you very much
Silvia
 

yodon

Staff member
Super Moderator
#2
Those are only answerable if the number and complexity of requirements are known (and I presume you're talking about the software system testing and not integration or any unit testing). Further, testing, especially for a new product is not a one-time thing; usually there are failures and, depending on the robustness of your requirements, may drive requirements changes / design changes that drive further testing. Part of testing is to ensure you have adequately covered all the requirements, typically through a trace tree analysis. If you don't have any automated trace tools, that's going to be a sizeable task on its own (to manually establish the traces).

Since you posted in the FDA section, there's a guidance for what FDA wants to see in submissions (despite 62304 being a recognized consensus standard) and a guidance for overall software validation.

And pretty much everyone now wants a cybersecurity assessment (which usually involves testing).

I always recommend a non-scripted set of exploratory tests to give the tester room to assess robustness. (These often find more issues than scripted verification protocols do!)
 
#3
Thank you very much yodon, really appreciate your answer.

We have contacted some SW companies and I think that we should start performing some initial tests for being able to provide to the SW company a better idea of what our SW will require.

However, I would like to ask you if, from your experience, you could provide us with a range of prices, even if they're very naive, so our investors could have a general idea of the costs (they are insisting a lot....)


Thank you very much again!

Silvia
 
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