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:
File | Dimensione | Formato | |
---|---|---|---|
119201Q_VASCOVID_PHANTOM.pdf
Accesso riservato
Descrizione: Articolo principale
:
Publisher’s version
Dimensione
717.72 kB
Formato
Adobe PDF
|
717.72 kB | Adobe PDF | Visualizza/Apri |
ECBO_VASCOVID_phantom_submit_final.pdf
accesso aperto
Descrizione: Pre-print
:
Pre-Print (o Pre-Refereeing)
Dimensione
632.31 kB
Formato
Adobe PDF
|
632.31 kB | Adobe PDF | Visualizza/Apri |
I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.