Paper
9 December 2021 Phantoms for performance verification and quality control in developing a photonics-based medical device (VASCOVID): a regulatory driven approach
Author Affiliations +
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.
© (2021) COPYRIGHT Society of Photo-Optical Instrumentation Engineers (SPIE). Downloading of the abstract is permitted for personal use only.
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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KEYWORDS
Control systems

Manufacturing

Biomedical optics

Liquids

Solids

Standards development

Medical device development

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