We propose a standardized approach for performance assessment and quality-control of the novel VASCOVID system based on optical phantoms. This approach is tailored to meet the requirements of the Medical Device Regulation, and is extendable to other biophotonics devices.

Phantoms for performance verification and quality control in developing a photonics-based medical device (VASCOVID): A regulatory driven approach

Zanoletti M.;Lanka P.;Lacerenza M.;Buttafava M.;Torricelli A.;Pifferi A.;Contini D.;
2021

Abstract

We propose a standardized approach for performance assessment and quality-control of the novel VASCOVID system based on optical phantoms. This approach is tailored to meet the requirements of the Medical Device Regulation, and is extendable to other biophotonics devices.
Progress in Biomedical Optics and Imaging - Proceedings of SPIE
9781510647060
9781510647077
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11311/1207260
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