Regulatory Science Tools Catalog
![MID](/sites/default/files/styles/card_large_image/public/2024-01/MID.jpg?h=4f4ef907&itok=creHJZ75)
A mathematically easy to understand and experimentally simple method to quantitatively and objectively evaluate endoscope geometric distortion
![Materials Program Image](/sites/default/files/styles/card_large_image/public/2023-12/Materials4.png?h=de93cae1&itok=DKI6GHTv)
A tool to determine the extractables profile of additive-manufactured orthopedic casts produced by fused filament fabrication method
![Cardiovascualar](/sites/default/files/styles/card_large_image/public/2024-01/Cardiovascular2.jpg?h=38fa3d21&itok=TQicflPH)
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
![Cardiovascualar](/sites/default/files/styles/card_large_image/public/2024-01/Cardiovascular2.jpg?h=38fa3d21&itok=TQicflPH)
A simple and compliant fluid reservoir appropriate for in-vitro blood trauma testing.
![Orthopaedics](/sites/default/files/styles/card_large_image/public/2024-01/Ortho.png?h=b93ac7c1&itok=gfXlA9BQ)
Provides 16 mock intervertebral body fusion device (that is, a spinal cage) designs with three lattice structure implementations. Designs are provided in stereolithography (STL) file format so they may be fabricated using additively manufacturing (AM) technologies.
![Cardiovascualar](/sites/default/files/styles/card_large_image/public/2024-01/Cardiovascular2.jpg?h=38fa3d21&itok=TQicflPH)
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.
![CM&S Program Image](/sites/default/files/styles/card_large_image/public/2023-12/CM%26S.png?h=86648cd7&itok=kJMvoS7O)
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.
![Cardiovascualar](/sites/default/files/styles/card_large_image/public/2024-01/Cardiovascular2.jpg?h=38fa3d21&itok=TQicflPH)
An implementation of a canine action potential model appropriate for comprehensive parameter sensitivity analysis and uncertainty quantification
![Materials Program Image](/sites/default/files/styles/card_large_image/public/2023-12/Materials4.png?h=de93cae1&itok=DKI6GHTv)
Conduct screening level risk assessments to aid in the biocompatibility evaluation of bulk additives and impurities in polymeric medical device components
![Materials Program Image](/sites/default/files/styles/card_large_image/public/2023-12/Materials4.png?h=de93cae1&itok=DKI6GHTv)
CHemical RISk calculators (CHRIS) – Color Additives (v2)
![Materials Program Image](/sites/default/files/styles/card_large_image/public/2023-12/Materials4.png?h=de93cae1&itok=DKI6GHTv)
Predicts the impact of extraction conditions, sample geometry and material properties on extraction test efficiency
![MID](/sites/default/files/styles/card_large_image/public/2024-01/MID.jpg?h=4f4ef907&itok=creHJZ75)
A software program written in Matlab for analyzing color performance testing data in endoscopy devices
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