Doctors and other health professionals expect medical devices to assist them more and more during diagnosis and treatment.
At the same time, there is a revolution underway in the medical devices industry – putting embedded software at the heart of many complex and critical devices. As the number and complexity of these medical devices continue to rise, so does the demand for safety and efficiency. Yet industry regulation has struggled to keep up.
For example, regulation to date has failed to consider the software’s own role as a medical device, ignoring thousands of health apps for patients and health professionals that are available without stringent checks.