Simulated Use Justification

A Foundation for
Application-Specific Validation

RESEARCH-INFORMED MODELS
BUILT FOR REAL-WORLD APPLICATIONS.

Our standard silicone models are designed to provide representative anatomy for training, testing, device evaluation, and procedural simulation. Each model is developed using published literature, medical imaging references, client feedback, and internal design inputs to reflect relevant anatomical dimensions and features.

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Simulation Today,
Better Outcomes Tomorrow.

Evidence-Based Design

Developed using published anatomical and clinical literature, medical imaging references, client feedback, and internal design inputs.

Within Human Variation

Model dimensions and design characteristics are selected to represent anatomy within documented ranges of human anatomical variation.

Documented References

Each model’s Simulated Use Justification document provides the reference basis for the anatomical dimensions and characteristics incorporated into the design.

Collaborate With Experts

Use the documented references in collaboration with your Key Opinion Leaders (KPIs), clinical experts, and regulatory teams to determine which anatomical characteristics are relevant to their intended use and establish acceptance criteria.

Supports Your Validation

The Simulated Use Justification serves as a supporting resource for customers evaluating and validating a model for their own application.

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Your Application,
Our Support.

We’re committed to providing the information you need to make informed decisions and advance innovation with confidence.

Important Note

Because application requirements vary, the Simulated Use Justification document does not establish suitability or regulatory validation for any specific application. Instead, it provides a research-informed foundation for customers to assess the model against their own clinical, technical, and regulatory requirements.