HARDWARE AND SOFTWARE DEVELOPMENT FOR SAFETY-RELATED MEDICAL DEVICES

摘要

Article addresses various aspects of system level design of a safety-related medical device. The main factors influencing the design and its division between software and hardware are: main hazards, intended use of the device and severity of a potential failure. Other factors include probability of change, testability and volume of production. End user's profile, time-to-market and life cycle of the device are also reviewed. The impact of both domestic and international regulations is discussed. A high level design process of an example medical laser is presented.