Applied ISO14971 Medical Device Risk Management

Description

In this course, you will :

• Understand the ISO14971 medical device risk management requirements and sequence
• Understand the roles and responsibilities of a risk management team
• Construct a risk management plan
• Apply the FMEA and 5×5 matrix in risk analysis
• Understand the relationship between risk evaluation, risk control and medical device testing
• Iterate the risk management process to evaluate residual risks
• Use risk/benefit analysis to assess residual risks
• Apply the Fault-Tree and Event Tree Analysis to evaluate residual risks
• Understand the importance of the risk management file
• Understand the type of post-production information required
• Dealing with unforeseeable risks in risk evaluation