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Regulatory Science Tools Catalog

HDI
A performance-based method requiring controlled grasping, transport, and release of objects that can be used to evaluate upper limb functional ability.
MID
The Virtual Family provides detailed three-dimensional computational models of the human anatomy including an adult male, an adult female, and two children
CM&S Program Image
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
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
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
Conduct screening level risk assessments to aid in the biocompatibility evaluation of bulk additives and impurities in polymeric medical device components
Orthopaedics
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.