Medical software

"[17] Due to the broad scope covered by these terms, manifold classifications can be proposed for various medical software, based for instance on their technical nature (embedded in a device or standalone), on their level of safety (from the most trivial to the most safety-critical ones), or on their primarily function (treatment, education, diagnostics, and/or data management).

SaMD, on the other hand, operates independently of a hardware device and is designed to fulfill a medical purpose on its own.

The dramatic increase in smartphone usage in the twenty-first century triggered the emergence of thousands of stand-alone health- and medical-related software apps, many falling into a gray or borderline area in terms of regulation.

"[20] Examples of mobile apps potentially covered by the guidance included those that regulate an installed pacemaker or those that analyze images for cancerous lesions, X-rays and MRI, graphic data such as EEG waveforms as well as bedside monitors, urine analyzers, glucometer, stethoscopes, spirometers, BMI calculators, heart rate monitors and body fat calculators.

Examples include software that controls a artificial cardiac pacemaker, manages infusion pumps, or operates imaging systems like MRI machines.

Additionally, ISO 13485:2016 specifies requirements for a quality management system in the design and manufacture of medical devices, including software components.

Furthermore, though not mandatory, they may elect to obtain certification from a notified body, having implemented such quality system requirements as described within international standards such as ISO 13485:2016.