ABSTRACT
Patients expect a safe healthcare system. Manufacturers of medical products employ strict quality assurance processes and both the process and the products are required to fulfil national and international safety regulations. These regulations often also apply to in-house developed medical devices, such as in-house developed software. This chapter provides an introduction and overview of the current regulatory frameworks with a focus on the EU- and FDA-regulations, and how they may apply to in-house developed medical devices and to management of health information privacy.
