Medical Device 2012 - Medical Device Risk Management Using ISO 14971

This webinar explains the application of Risk Management for medical devices using ISO 14971:2007. It explains the flow of information from the Risk Management Plan to the Risk Management Report, looking at important terms including Hazard, Harm, and Risk and explaining how to use each one.

ISO 14971:2007 is the de facto standard for medical device risk management. It requires more than just Risk Assessment or an FMEA.ISO 14971:2007 is the de facto standard for medical device risk management. It requires more than just Risk Assessment or an FMEA. Your Risk Management program should be able to answer these questions easily. If not, then your team needs to attend.