Risk and Hazard Assessment for Medical Devices - ISO 14971 - ComplianceOnline (Risk and Hazard Asse)

Venue: Online

Location: Palo Alto, California, United States

Event Date/Time: Apr 24, 2009
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Description

This program introduces the concepts of Risk and Hazard Assessment from ISO 14971:2007. It covers the differences among Hazard, Harm, and Risk and explains how to evaluate each of them. The program describes development of a Risk Evaluation Matrix taking into account the probability of occurrence and the severity of the harm. The standard requires a list of known and foreseeable hazards as well as foreseeable sequences of events that could result in harm. The presentation describes the tools (FMEA, FTA, and HACCP) and helps you start to apply them.

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Additional Information

This program introduces the concepts of Risk and Hazard Assessment from ISO 14971:2007. It covers the differences among Hazard, Harm, and Risk and explains how to evaluate each of them. The program describes development of a Risk Evaluation Matrix taking into account the probability of occurrence and the severity of the harm. The standard requires a list of known and foreseeable hazards as well as foreseeable sequences of events that could result in harm. The presentation describes the tools (FMEA, FTA, and HACCP) and helps you start to apply them.