Designing a Pharmacogenetic Test as a Medical Software Device

Abstract

Most people have genetic mutations which influence the efficacy of drugs and when taken into account, could improve health response. A pharmacogenetic test performed on the patient’s genetic data is a possible solution. Although the test merely provides a software-based analysis of already existing genetic data, the test still classifies as a medical software device. This thesis gives an overview of pharmacogenetics, software-based medical devices, formulates requirements for such a device, provides a high level design, verifies the design against requirements, and discusses the results and perspectives.