This paper outlines a software process improvement (SPI) framework to ensure regulatory compliance for the software developed in medical devices. The software framework introduced here (known as MedeSPI – Medical Devices Software Process Improvement) will address an opportunity to integrate the regulatory issues and process improvement mechanisms in order to achieve improved software processes within a number of process areas that are critical to the development of software for medical devices [3]. The paper then describes in detail how the goals, practices and capability levels for the risk management process area within the MedeSPI framework have been developed.
Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (FDA) [4] (US requirement), and the European Commission under its Medical Device Directives (MDD) [2] (CE marking requirement) is achieved. Integrated into the design process of medical devices, is the requirement of the production and maintenance of a device technical file, incorporating a design history file. Design history illustrates the well documented, defined and controlled processes and outputs, undertaken in the development of medical devices and for our particular consideration with this framework - the software components.