Quality Assurance When Developing Software with a Medical Purpose

Abstract

In the field of development of scientific or medical software, questions may arise, such as how we define if software has a “medical purpose,” what regulations may apply and how they influence the (projected) pathway. We may find ourselves embroiled with the new “In Vitro Diagnostics Regulation” (IVDR) and its implementation in organizations. In this chapter we will attempt to summarize and order key bits of information, as found in these standards and related publications, that seemed relevant along the way in our software development processes. After this we will try to expose possible pitfalls that could be encountered. We also reach out to (existing) methodologies that may aid in the endeavor to the realization of software. Top-down risk approaches consider hierarchical ordering of priorities based on process levels where context and meaning play a more significant role over content and documentation. To honor the different sources, we will seek to outline how this led to a form of understanding that allowed the development of software. Maintaining a high standard of risk control while keeping focus on product realization. Hopefully these outlines and referred source materials may bring slight relief to others on a similar quest.