IEC 62304 - Software verification cost

silviaguerra

Registered
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.

Highlt appreciate it,
Thanks,
Silvia
 

shimonv

Trusted Information Resource
It greatly depends on how complicated is the software and him much of the software QA docs you have. You will probably need to run the test plan several times because of software bugs.
Best to start getting quotes from testing subcontractors.

Shimon
 

Tidge

Trusted Information Resource
It's impossible to answer the question as asked primarily because 62304 is a process standard and not a product standard. In order to answer the question a qualified software engineer/project manager would need to know some details about the product (or project) to make an estimate. A trustworthy resource will also share the basis for their estimate. A rather simple (old-school) metric that has been used to estimate testing efforts is lines-of-code. A test estimate for 62304-compliant software would depend on elements of 62304 (requirements, architecture). There is a subtle issue with testing of class B and C software: Class B does not require detailed designs for individual software units, but it does require verification of the (acceptance criteria for) individual units for both class B and C. Without enough details of the units (in class B software elements) in can be difficult to establish verification of those units.

I like Roger Pressman's chapter on Software Project Estimation as a good place to start to learn all sorts of things, but especially project management and project estimation.

More important that simply focusing on the testing of ME device software is the development of ME device software.
 

silviaguerra

Registered
Thank you very much for all your answers, very very hekpful!

The truth is that we have already asked some software companies and specialised engineeres to provide as a cost for the tests, and they told us what you have previously commented: they need some preliminary tests to determine the exact price.

On the other hand, the investors of the project insist a lot on having a general idea of the cost for the SW verification....

It's like a vicious circle that never ends...

For this reason I wanted to ask you if you could provide me with a price range, even if it is very naive. We will be very grateful!


Thanks again for all your responses, we appreciate it.

Silvia
 
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