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Regulatory Science Tools Catalog

Materials Program Image
Conduct screening level risk assessments to aid in the biocompatibility evaluation of bulk additives and impurities in polymeric medical device components
Cardiovascualar
An implementation of a canine action potential model appropriate for comprehensive parameter sensitivity analysis and uncertainty quantification
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.
MID
A software program written in Matlab for analyzing color performance testing data in endoscopy devices