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
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