Module 14: Design Development and Certification of Medical Devices

17/11/2023

RISK ANALYSIS / RISK EVALUATION

 Determine the ACCEPTABILITY of each risk  Eliminate or reduce each risk AS FAR AS POSSIBLE  Re-design  Process validation  Process variability reduction  Labelling / user education  Evaluate the controls and solutions adopted (risk reduction measures)  Re-assess the acceptability of each risk

Masterclass: Lecture 2

45

OVERALL RESIDUAL RISK

 Evaluate the OVERALL risk for acceptability

 DOCUMENT the process!

 CONTINUE TO MONITOR

 Were your original assumptions correct?  Do the risks remain acceptable throughout the life cycle of the device?

Masterclass: Lecture 2

46

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