IEC 62304 software costs and time

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

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!)

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

We have done a 62304 review of a class B software product with TUV and the cost was approx. $4,500 for the review/report.