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

Sanathana Konugolu Venkata Sekar; Claudia Nunzia Guadagno; Marta Zanoletti; Lorenzo Cortese; Marco Pagliazzi; Pranav Lanka; Rainer Rothe Munoz; Eduardo Garrido; Talyta Carteano; Michele Lacerenza; Mauro Buttafava; Shahrzad Parsa; Udo M. Weigel; Alessandro Torricelli; Antonio Pifferi; Davide Contini; Turgut Durduran; Stefan Andersson-Engels

doi:10.1117/12.2615398

9 December 2021 Phantoms for performance verification and quality control in developing a photonics-based medical device (VASCOVID): a regulatory driven approach

Sanathana Konugolu Venkata Sekar, Claudia Nunzia Guadagno, Marta Zanoletti, Lorenzo Cortese, Marco Pagliazzi, Pranav Lanka, Rainer Rothe Munoz, Eduardo Garrido, Talyta Carteano, Michele Lacerenza, Mauro Buttafava, Shahrzad Parsa, Udo M. Weigel, Alessandro Torricelli, Antonio Pifferi, Davide Contini, Turgut Durduran, Stefan Andersson-Engels

Author Affiliations +

Proceedings Volume 11920, Diffuse Optical Spectroscopy and Imaging VIII; 119201Q (2021) https://doi.org/10.1117/12.2615398
Event: European Conferences on Biomedical Optics, 2021, Online Only

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.

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Sanathana Konugolu Venkata Sekar, Claudia Nunzia Guadagno, Marta Zanoletti, Lorenzo Cortese, Marco Pagliazzi, Pranav Lanka, Rainer Rothe Munoz, Eduardo Garrido, Talyta Carteano, Michele Lacerenza, Mauro Buttafava, Shahrzad Parsa, Udo M. Weigel, Alessandro Torricelli, Antonio Pifferi, Davide Contini, Turgut Durduran, and Stefan Andersson-Engels "Phantoms for performance verification and quality control in developing a photonics-based medical device (VASCOVID): a regulatory driven approach", Proc. SPIE 11920, Diffuse Optical Spectroscopy and Imaging VIII, 119201Q (9 December 2021); https://doi.org/10.1117/12.2615398

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