While the rapid advancement of medical technology has led to enormous healthcare benefits, it has also brought potentially life threatening software issues that device makers must overcome. Like a vital organ, medical devices need continuous security and quality maintenance throughout their entire lifecycle, from inception to retirement.
This white paper on FDA software validation shows that with testing gates at each phase of the software development life cycle (SDLC), device manufacturers can establish secure software development practices that manage quality, security,and safety of medical devices in accordance with FDA guidance.