Medical Device Development

Abstract

This chapter gives you an overview of essential points to be considered during the development phase in the life cycle of a medical device. The chapter begins with an introduction of regulatory requirements from a European and US perspective, covering the relevant international requirements during development. This is followed by a conceptional development model with user needs, design input, design output, and verification and validation through to the finished device, accompanied by project management and quality assurance. The reader will find not only some basic thoughts for the most common development models, but also some notes highlighting essential points in each phase. In addition, the reader will also find some considerations on processes in the development phase as well as on effort allocation of resources during the development. Some supporting processes to the development process are also mentioned to give a holistic picture of what to consider when developing a medical device.