System Design Approach to Medical Device Development

Abstract

Many life saving devices come with significant risk which must be mitigated through a defined system design process. A seamless integration of the design and development process and the safety risk management process will allow devices to be safety used on humans. The development process is described in ISO 13485, the international standard for the development of medical devices. ISO 14971 is the international standard for the evaluation of the safety risk of a medical device. A system engineering approach to the design of medical devices provides a holistic approach to ensuring these devices are safe for their intended use. Universities and companies hoping to use their devices in clinical trials on patients are required to follow a well-defined process incorporating design and development planning, design input, design output, design review, design verification, and design validation. The safety risk management process must be carefully overlaid on top of this standard development process. This paper will describe acceptable development processes, including agile and evolutionary design. It will also describe the methodology used to develop devices intended for clinical trials on patients, prior to commercialization. It will briefly describe the requirements of clinical trials performed on humans and will cover the key elements of the safety risk management process.