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Regulatory Science Tools Catalog

This regulatory science tool presents an open-access dataset tool for the assessment of wearable technology deriving gait parameters.
This tool provides a benchmark validation data set for laminar flow in an anatomical vascular model of the inferior vena cava (IVC).
This RST is a database tool consisting of nine mock circulation loop (MCL)-generated datasets for characterizing three dynamic attributes of pressure-based cardiac output monitoring systems that apply an algorithm to intra-radial arterial blood pressure waveforms for cardiac output and stroke volume variation measurements.
Materials Program Image
The DAMSEL tool is a digital collection of published information related to the safety profile of materials commonly used in the manufacture of medical devices. This interactive application allows users to filter and access key response data for studies relating to material biocompatibility along with hyperlinks to the relevant original studies.
CM&S Program Image
A "threshold-based" validation approach that provides a well-defined acceptance criterion, which is a function of how close the simulation and experimental results are to the safety threshold, for establishing the model validity.