There are similar issues with this in Structural and Mechanical engineering. Engineers are expected to rely more and more on software to execute and document complex calculations to verify designs, but how can you be sure those underlying calculations&#x2F;theorems&#x2F;models are correctly implemented? Some packages are constantly patching particular edge cases that get sent to them from their users. Many issue announcements to warn of bugs that could cause an incorrect result.<p>If a result from software led to a critical failure in a design, the onus is most likely still on the Engineer.<p>I have seen cases where software is formally reviewed by independent verification bodies, much in the same way your ISO 9001 compliance is. I can&#x27;t see why this wouldn&#x27;t apply here. Have an independent party, who has signed an appropriate NDA, asses and certify that your product does what it says on the tin and audit it at regular periods.