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An Automated Model to Estimate the Probability of a Use Error Related Adverse Event for In Vitro Diagnostic Medical Devices

Description:

The FDA, the MHRA, and other regulatory authorities recommend that during the development process of a device, manufacturers should aim to understand the use errors of comparable devices to the ones of interest. Knowing the probability and severity of use errors for similar products, they can be...

Keyword:

Use Error, Machine Learning, Human Factors Engineering, MAUDE Database, IVD Device, and Adverse Event

GW Unit:

Engineering Management

Degree:

D.Engr.

Advisor:

Grenn, Michael

Committee Member(s):

Malalla, Ebrahim and Etemadi, Amir

Resource Type:

Thesis or Dissertation