The rapid advancement of technology has revolutionized the healthcare industry, introducing innovative approaches to diagnosis, treatment, and patient care. Software as a Medical Device (SaMD) has emerged as a game-changer among these transformative technologies. SaMD refers to software intended to serve medical purposes without being part of a hardware medical device. Instead, it operates independently, utilizing advanced algorithms and analytics to provide accurate and timely diagnosis, monitoring, and treatment insights.
In this white paper, we examine the regulatory framework established by the International Medical Device Regulators Forum (IMDRF) and highlight the benefits, opportunities, and how the healthcare business could be revolutionized by SaMD implementation.