Risk Management System for Medical Standalone Software

According to update of Medical Device Directive (MDD) by European Union in 2007, the software as such can be a medical device. The direct consequence of the change of the directive is, that now depending on the intended use of software, the software might be regulated according to the MDD. If the software is classified to be a medical device, manufacturer has to fulfill the requirements of MDD to get CE mark for software. Most of the requirements are fulfilled by using three standards: IEC 62304 Software life cycle processes, ISO 14971 Application of risk management to medical devices and ISO 13485 Quality management systems. The purpose of the thesis is to discuss the influence of regulation to medical device, classified as software, globally and in Europe and also the influence of three mandatory standards. The risk management standard is processed in more detail and the develop-ment of risk management system is based on it. The risk management system was con-structed according to characteristics of medical standalone software. The goal of the thesis was to model the risk factors in the software environment and build the risk man-agement system around the model. The risk management system is based on the Risk factors model, which is developed in this thesis. In the model, the use of software was divided into seven factors that together or alone could contribute a hazardous situation in using the software. The developed risk management system consisted of four parts: preliminary planning, software development, post-production use and operation, and production and post-production information collecting system. The risk management system is one of the essential requirements to launch new medical device. For a software, which is classified as a medical device there is no established a way to fulfill the regulative requirements of risk management system, because the change in the MDD is new. The thesis presents one approach to fulfill the requirements and produce more safe software. /Kir11