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

Autor: Sekar, S. K. V., Guadagno, C. N., Zanoletti, M., Cortese, L., Pagliazzi, M., Lanka, P., Munoz, R. R., Garrido, E., Carteano, T., Lacerenza, M., Buttafava, M., Parsa, S., Weigel, U. M., Torricelli, A., Pifferi, A., Contini, D., Durduran, T., Stefan Andersson-Engels
Rok vydání: 2021
Zdroj: Scopus-Elsevier
DOI: 10.1117/12.2615398
Popis: 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.
Databáze: OpenAIRE