Where: ALTEN Technology

For: Abram Scientific

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ALTEN Technology partnered with Abram Scientific to support product development of the CoagCare system. As the QE on ALTEN's team, I provided review of requirements and support with ensuring the requirements were SMART. I also identified relevant standards to which the predicate device to CoagCare were traced with their applicable revs by referencing the FDA Database, 510k submissions, and prior biomedical industry knowledge. Additionally, I helped perform the uFMEA and dFMEA, during which I was able to leverage my ASQ Risk Management Certification. Aside from risk management benefits, FMEA furthered the requirements development by serving as a reference for gap analysis. Another contribution I made to the project was devising the SOUP Validation Plan. The plan covered anticipated validation activities, validation protocols, defined the configuration of the CoagCare SOUP, provided rationale for waiver of certain validation, and identified the requirements against which the validation would be performed. In identifying which requirements to validate, I determined which requirements would be validated through nominal verification testing to eliminate redundancy and optimize efficiency and how working functionality of feature(s) possibly related to intended use (and in turn directly validate the SOUP intended use). This project began in 04/2022 and ended 10/2023.