Applying risk management principles to medical devices performance assurance program-defining the process.
D000465:Algorithms; D004868:Equipment Failure; D019544:Equipment Failure Analysis / Q000379:methods*; D004864:Equipment and Supplies; D011785:Quality Assurance, Health Care / Q000379:methods* / Q000458:organization & administration*; D012308:Risk Management / Q000458:organization & administration*; D014481:United States