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. The program describes development of a Risk Evaluation form that implements the requirements of ISO 14971.
Why Should You Attend:
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.
- Do you have a documented method to combine frequency and severity to calculate risk?
- Do have a formally approved Risk Management Plan that applies to your medical device?
- Do you apply risk reduction methods in the correct order?
- Have you documented the risk verification in the Risk Management Report?
- Does your manufacturing process control, especially validated processes, regularly update you Risk Management File?
- Have you integrated you complaint system with the Risk Management File to evaluate your frequency and severity estimates?