Module 19 2021

02/06/2021

Practical Implementation

Risk Management Reporting  Review of process with respect to plan  Top management acceptance of process implementation  Overall risk statement

Is the product safe and effective?

Is there benefit of having device on market?

29

Post-Production Activity

Post Market Surveillance • Continuous assessment of the risk-benefit of the device • Complaints • Design Changes • Takes into account customer feedback, state of the art • Beware accumulative design changes and impact of residual risk

30

15