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Filtering by: Advisor Grenn, Michael Keyword Adverse Event Type of Work Thesis or Dissertation

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:

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

GW Unit:

Engineering Management

Degree:

D.Engr.

Advisor:

Grenn, Michael

Committee Member(s):

Etemadi, Amir and Malalla, Ebrahim

Resource Type:

Thesis or Dissertation