Regulatory Science Tools Catalog
![MID](/sites/default/files/styles/card_large_image/public/2024-01/MID.jpg?h=4f4ef907&itok=creHJZ75)
The Virtual Family provides detailed three-dimensional computational models of the human anatomy including an adult male, an adult female, and two children
![HDI](/sites/default/files/styles/card_large_image/public/2024-01/HDI.jpeg?h=4732d095&itok=0Ffvk3qy)
A performance-based method requiring controlled grasping, transport, and release of objects that can be used to evaluate upper limb functional ability.
![MID](/sites/default/files/styles/card_large_image/public/2024-01/MID.jpg?h=4f4ef907&itok=creHJZ75)
A tool to generate computational scientific evidence as alternative approaches to clinical
![CM&S Program Image](/sites/default/files/styles/card_large_image/public/2023-12/CM%26S.png?h=86648cd7&itok=kJMvoS7O)
This study demonstrates the application of gold-standard method of manufactured solutions (MMS) code verification to verify a commercial finite element code for elastostatic solid mechanics analyses relevant to medical devices. The Python/SymPy code used to generate source terms is available as supplemental material.
![Orthopaedics](/sites/default/files/styles/card_large_image/public/2024-01/Ortho.png?h=b93ac7c1&itok=gfXlA9BQ)
Lumbar Integrated Fixation Devices-Best Practices for Biomechanical Evaluation Under Fatigue Loading
Recommended best practices for executing in vitro human cadaver fatigue loading and multidirectional flexibility assessment of lumbar integrated fixation device constructs.
![CM&S Program Image](/sites/default/files/styles/card_large_image/public/2023-12/CM%26S.png?h=86648cd7&itok=kJMvoS7O)
A finite element model of the human shoulder for simulating humeral abduction and calculating outputs such as contact force, contact pressure, contact area, stress, and strain.
![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
![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.