ISO 14971 - Medical Device Risk Management

ISO 14971 - Medical Device Risk Management and Hazard Control: Identifying and controlling the risks and the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices.
FAQs
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ISO 14971 Medical Device Risk Management FAQ
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zoneofindifference
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Marc
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Are you looking for ISO 31000 - Risk Management Principles and Generic Guidelines?
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Stijloor
Stijloor
Marc
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The US's FDA and other Medical Device Related Forums
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Marc
Marc
Discussions
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Will Basic UDI-DI be related to product recalls?
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Busra Yavuz
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Failure modes for Inspection processes
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Bev D
Bev D
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Supplier risk management
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perinad
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Risk Management ISO 14971 - Probability of Occurrence
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Bev D
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Estimation of risk reduction prior to verification of effectiveness
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d_addams
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Risk number - same (calculated) number for acceptable & not acceptable risk, how to handle?
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Bev D
Bev D
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What is meant by "post production" if the device is yet to receive FDA approval?
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d_addams
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MAUDE Hazard Input
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d_addams
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Risk Analysis : 2 devices used in combination (hazard in device A, but harm using device B)
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TomQA
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Software user interface - definition of hazards
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AlexisRuiz27
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Ed Panek
ASQ Presentation Assistance
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Tidge
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What to include in the risk analysis table?
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Vetty007
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Classify/present risks in Risk Analysis table
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Vetty007
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How to align sequence of events in an Hybrid template of PFMEA and ISO 14971?
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Tidge
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Looking for help with Hematology Analyzers med device submission
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aelkhayat
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