Standards and Regulations for (Bio)Medical Software

Abstract

This chapter provides an introduction to the basic legal regulations and harmonized standards for the development and release of biomedical software, which is treated by law as a medical product. The authors will primarily focus on the regulations and recommendations within the European Union, and also delineate and discuss the legal situation exemplarily in selected countries such as the United States, Canada and Australia. In summary, this survey will provide a guideline for researchers and practitioners dealing with software development as a medical product according to the Medical Devices Act.