Stage 3: Conduct Risk Assessment (Model Risk)

In accordance with the previous ICH and ASME guidance (ICH Q9(R1), Q10, M15; ASME, 2018), a model risk assessment should be performed by considering both:

  • Model influence on the decision, and

  • Decision consequence if the model were incorrect.

The resulting risk classification should determine the required level of model credibility and the scope of verification and validation activities.

Links:

ICH Q9(R1): https://database.ich.org/sites/default/files/ICH_Q9%28R1%29_Guideline_Step4_2025_0115_0.pdf

ICH Q10: https://database.ich.org/sites/default/files/Q10%20Guideline.pdf

ICH M15: https://database.ich.org/sites/default/files/ICH_M15_EWG_Step2_DraftGuideline_2024_1031.pdf

ASME, 2018: https://www.asme.org/codes-standards/find-codes-standards/assessing-credibility-of-computational-modeling-through-verification-and-validation-application-to-medical-devices