Risk Management for Medical Devices - ASQ Raleigh：医疗器械的风险管理——ASQ罗利.pptVIP

Risk Management for Medical Devices Safe and Effective Products Paul McDaniel ASQ CQM/OE Executive VP Operations and QA Sicel Technologies Overview Product Life Cycle Model Role Process Hints In-depth discussion of a Risk Management Analytical Tool: FMEA Risk Management Defined(a practitioners definition) Risk: probability of harm occurring AND the severity of harm Risk Management: Use of relevant information to identify possible harmful events, to assess the event’s acceptability in the eye’s of the at risk population (probability*severity), and exert effective controls of the risk Produc