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.;
2021-01-01
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.File in questo prodotto:
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119201Q_VASCOVID_PHANTOM.pdf
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ECBO_VASCOVID_phantom_submit_final.pdf
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