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Proceedings Papers

Proc. ASME. DMD2022, 2022 Design of Medical Devices Conference, V001T10A006, April 11–14, 2022
Publisher: American Society of Mechanical Engineers
Paper No: DMD2022-1060
... (branch-out). We are preparing CETCS for regulatory pathway application to advance it further toward clinical and human trials. In this paper, we performed three performance tests: infusion pressure, leakage, and constant pressure flow rate tests required by the FDA to file a traditional 510(K) based upon...
Proceedings Papers

Proc. ASME. DMD2022, 2022 Design of Medical Devices Conference, V001T03A001, April 11–14, 2022
Publisher: American Society of Mechanical Engineers
Paper No: DMD2022-1045
... to the healthcare field, this research proposes a unique, standardized consumer privacy label for the FDA to implement, mirroring the design and success of the FDA nutrition label in educating consumers in healthy decision making. Device Cybersecurity FDA Consumers Proceedings of the 2022 Design...
Proceedings Papers

Proc. ASME. DMD2021, 2021 Design of Medical Devices Conference, V001T02A011, April 12–15, 2021
Publisher: American Society of Mechanical Engineers
Paper No: DMD2021-1085
... Abstract The Cardiovascular Research Program in OSEL at the FDA consists of a diverse group of engineers and scientists who seek to drive innovation in cardiovascular device technology through development and standardization of pre-clinical test methods using in vitro, in vivo, and in silico...