Module 15 2022

19/05/2022

Guidance that help clinical strategic thinking: DES

Use FMEA to discuss design and failure modes resulting in clinical risks

Show FDA in submission where to find supporting information (e.g. previous iteration of device)

Discuss why tests mitigate risks – leading to clinical study rationale

The Organisation for Professionals in Regulatory Affairs

25

Other Considerations

The Organisation for Professionals in Regulatory Affairs

26

13