The Application of Risk Management to Medical Software Example of the Picture Archiving and Communication System

Medical devices are significant risk when, among other things, they could be implant, invasive, life-supporting, or substantially important for di-agnosing, curing, mitigating, treating, or preventing impairment of humans. Especially, medical soft-ware is a specialized branch of software engineer-ing in which the software is used to monitor or con-trol patient functions and records. Once a malfunc-tion or a latent design flaw in the software of medi-cal device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to injury, even serious harm or death. According to ISO14971 for risk manage-ment of medical device, this paper attempts to ana-lyze the example of the Picture Archiving and Communication System (PACS). All of the risks would be implemented the analysis and done the necessary control by the ISO14971 relevant proce-dures; and any undesirable hazards would have been reduced to the acceptable levels.