In recent years, in the healthcare sector, software has become an important part of all products, integrated widely into digital platforms that serve both medical and non-medical purposes.
In particular, the development of software used in the medical device field has increased, due in part to the increased adoption of technology such as, smartphones, new sensors, cloud spaces, WI-FI connectivity, and artificial intelligence (AI), all of which are influencing healthcare delivery around the world.
In particular, the recent rise of artificial intelligence (AI) and machine learning (ML) has also led to the possibility of using real-world data to provide patients with predictive health information. In this way, the device is able to support the patient even when the physician is not present.
However, have you ever heard the term “Software as a Medical Device (SaMD)?