Regulatory Science Tools Catalog
Tool for assessing image quality of advanced nonlinear CT image reconstruction and denoising products, including but not limited to statistical iterative, model-based iterative, and deep learning-based methods
Best practices for standardized performance testing of infrared thermographs intended for fever screening
A Method Using 3D Printed Surrogate G-Tubes and Newtonian Analog Fluids to Compare the Flow Rates with Commercial Diets in G-Tubes with the New ISO 80369-3 Connector
A tool to determine the extractables profile of additive-manufactured orthopedic casts produced by fused filament fabrication method
A mathematically easy to understand and experimentally simple method to quantitatively and objectively evaluate endoscope geometric distortion
Non-clinical biomarkers of brain injury derived from epidermal and epidural electroencephalographs
A method to estimate device-specific noise from ECG records for algorithm testing
This tool provides a step-by-step protocol to design a recirculating flow loop test system and perform in vitro thrombogenicity testing of catheter-like blood-contacting medical devices and materials using blood from several animal species. The protocol also provides details about different markers for thrombogenicity testing.
A simple and compliant fluid reservoir appropriate for in-vitro blood trauma testing.
A tool to assist with evaluating and quantifying contractile response of non-excitatory electrical stimulation signals including CCM in vitro using 2D human cardiomyocyte models