Software as a Medical Device (SaMD): What It Is & Why It Matters

Over the last 40 years, the role of software both in and surrounding medical devices has dramatically increased. Software as a Medical Device (SaMD) brings new opportunities and new challenges for both device companies and for regulators. New regulatory paradigms are emerging to facilitate innovation while at the same time continuing to safeguard patient safety and clinical effectiveness. In this white paper, we explore Software as a Medical Device, look at the core aspects that define it as a new type of medical device and its benefits, and examine who stands to benefit the most from its ongoing rise.