Research cooperation with FDA

24.08.2017 - 14:25

On July 13, 2017, a Research Collaboration Agreement (RCA) was signed between U.S. The Food and Drug Administration (FDA) and the Gdansk University of Technology (GUT) for a period of 5 years. The goal of the agreement is to develop methods and tools supporting qualification of medical devices and safety assessment.

Collaborative research issues to be explored include methods of structuring and assessing assurance cases, methods of integrating assurance cases with the results of hazard analysis and system models, developing modular assurance cases that follow system – component decomposition, and applying evidence based arguments to demonstrate conformity with reference safety and security standards. The research work will include application of system NOR-STA created by GUT and since 2014 developed and enhanced by Argevide.

The research project is carried out by the team at Software Engineering Department (GUT) led by prof. Janusz Górski and at Center for Devices and Radiological Health (FDA) led by Paul Jones.

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