In the US at least, the regulation of software in medical devices regulates the process by which the software is developed and tested. The qualifications of th

In the US at least, the regulation of software in medical devices regulates the process by which the software is developed and tested. The qualifications of the people developing the code are somewhere down in the process-stack; there are no specific requirements [1]. In general, to follow "Current Good Manufacturing Practices" (a term of art in the FDA design controls regulation), qualifications for the people on the team have to be documented and a paper trail kept up-to-date, to be able to answer questions of the nature "was person <X> qualified to be working in this role? How do you know?" with objective evidence. It's up to the judgment of the engineering management of the project what they state the requirements of the role to be. If you say that it takes a high-school diploma or better to be able to develop life-safety-critical medical device software, you may pass a process audit since you document and track that requirement, but if there is an "adverse incident" I would think whoever signed off on that decision might be exposed to liability. [1] My specific knowledge about this is ~5 years out of date so this may have changed, but I doubt it