Medical Device Risk Management Using ISO 14971 - Webinar By ComplianceOnline (Medical Device)
Venue: Online Event
|Event Date/Time: Mar 23, 2012||End Date/Time: Mar 23, 2012|
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?
This course provides the attendees with an overview of ISO 14971:2007 and implementation tips for an effective system for managing risk. We provide an overview using flow charts that shows each of the elements of a Risk Management system and how they fit together. This approach helps the participant understand the essential structure and the required elements.