Comment Software used as a medical device... (Score 3, Informative) 227
is strictly regulated by the FDA. Not only is a software company required by law to obtain premarket approval 510(k) from the FDA before marketing certain types of medical software in the US, but it is also required by law to document and follow a very thorough software development and validation process.
Although this kind of software is usually not sold to the general public, it is used every day in hospitals and clinics to do everything from analyzing bacterial infections to robotic surgery to radiation oncology treatment planning.
I have worked for several software companies, developing software that is considered a class II medical device. Not only did we have to completely document everything from requirements to validation testing, but we had to keep the documents themselves under version control! Knowing that your software could mean life or death to someone, really puts the software engineering process into perspective.
Although this kind of software is usually not sold to the general public, it is used every day in hospitals and clinics to do everything from analyzing bacterial infections to robotic surgery to radiation oncology treatment planning.
I have worked for several software companies, developing software that is considered a class II medical device. Not only did we have to completely document everything from requirements to validation testing, but we had to keep the documents themselves under version control! Knowing that your software could mean life or death to someone, really puts the software engineering process into perspective.
