title: Risk management in the design of medical device software systems.
abstract: The safety of any medical device system is dependent on the application of a disciplined, well-defined, risk management process throughout the product life cycle. Hardware, software, human, and environmental interactions must be assessed in terms of intended use, risk, and cost/benefit criteria. This article addresses these issues in the context of medical devices that incorporate software. The article explains the principles of risk management, using terminology and examples from the domain of software engineering. It may serve as a guide to those new to the concepts of risk management and as an aide-memoire for medical device system/software engineers who are more familiar with the topic.
authors.affiliation: Center for Devices and Radiological Health, Food and Drug Administration, 12720 Twinbrook Parkway (HFZ-141), Rockville, MD 20857, USA. pxj@cdrh.fda.gov
authors.forename: Paul L
authors.initials: PL
authors.lastname: Jones
authors.forename: Joseph
authors.initials: J
authors.lastname: Jorgens
authors.forename: Alford R
authors.initials: AR
authors.lastname: Taylor
authors.forename: Markus
authors.initials: M
authors.lastname: Weber
mesh_terms: D003257:Consumer Product Safety; D004282:Documentation / Q000379:methods / Q000592:standards; D004582:Electronics, Medical / Q000295:instrumentation / Q000592:standards*; D004867:Equipment Design; D004869:Equipment Safety / Q000379:methods / Q000592:standards*; D004864:Equipment and Supplies; D010934:Planning Techniques; D011786:Quality Control; D018570:Risk Assessment / Q000379:methods / Q000592:standards; D012308:Risk Management / Q000379:methods* / Q000592:standards*; D017751:Safety Management / Q000379:methods / Q000592:standards; D012984:Software / Q000592:standards*; D012985:Software Design; D012986:Software Validation; D017749:Total Quality Management; D014481:United States