Defining the role of software quality assurance in a medical device company

The use of software by medical device companies is growing exponentially. In addition to software providing major functionality of medical functionality of medical devices, software is being used to manufacture medical devices, and to validate the efficacy of medical devices prior to use. Many medical device companies have implemented software quality assurance programs to ensure software products and software development processes conform to established requirements. In most cases, however, these programs are not well defined, resulting in inconsistent support between projects. The author provides the framework used by one medical device company to define their software quality assurance program