Software in medical devices, stand-alone, as an app or health software
We encounter software in medical technology in many forms: as embedded software on the controllers of a medical device or in the Graphic User Interface (GUI), as standalone software (SaMD = software as a medical device), as network, database and cloud software. Or in the Internet of Medical Things (IoMT), as a medical app, digital health application (DiGA) or health software – here possibly not a medical device if focused on health, fitness or nutrition.
Medical software must be developed, documented and maintained according to ordered processes – the so-called software lifecycle processes.
The foundations for this have been laid in the two international standards IEC 82304-1 and IEC 62304, among others. Depending on the type of software, their design can vary. There is also no specific process model prescribed, so that both classic V-model and agile development can be used.
The requirements of the Medical Device Regulation (MDR) 2017/745 and the In vitro Diagnostic Medical Device Regulation (IVDR) also apply to medical software. In some cases, new ways of thinking and proceeding are required here, for example in clinical evaluation or performance assessment.