The healthcare industry is witnessing many changes in this digital era. One such trend is in software and its impact on how clinicians practice medicine, how consumers manage their own health, and how patients and healthcare providers interact.
In particular, a recent revolutionary development in digital health technology is software that can perform complex medical functions - software as a medical device (SaMD). In the past, software was simply an ancillary component of a medical device, which was based on hardware. These days, software frequently has a primary role, and in many cases, it is the core of the medical device. As a result, software is becoming more complex and the risk associated with it, compounded.
Download this white paper and discover why implementing a regulatory strategy early in the development will go far in bringing you closer to successful market access of your SaMD.