Certification and regulatory challenges in medical device software development

Abstract

The critical nature of safety in medical device software requires a repeatable and compliant software engineering process. This process should take into account the whole development life cycle, risk management, and software verification and validation activities that would commensurate with the device's complexity and risk. This paper discusses some of the key challenges medical device manufacturers are facing in the development and certification of medical device software. These challenges include: compliance with the EU and US regulatory requirements for medical device software, making software development and maintenance processes more agile in the medical device regulatory environment, integrating usability engineering process/human factors into software development, regulation of networked medical devices and mobile medical applications (apps). The MED-EL case study highlights some of the challenges described in this paper, and the approaches taken to overcome these challenges.