Effectively incorporating risk management into quality systems.
Medical device manufacturers do not always recognise that the process of identifying and controlling risks is most effective if risk-related activities are incorporated into their quality systems. This article discusses a guidance document that provides practical suggestions for accomplishing this important task.
Donawa
Maria
M
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D020811:Biomedical Technology; D004867:Equipment Design / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D011786:Quality Control; D012308:Risk Management / Q000592:standards*