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In‑Vitro Validation of Computational Models (ASME V&V 40)

(Individual)

Computational modeling is a powerful tool for predicting medical device performance — but its credibility hinges on how well those predictions match reality. Under ASME V&V 40, validation must be grounded in evidence that reflects the model’s intended use and associated risk. For many devices, the most reliable and controllable source of this evidence comes from high‑fidelity in‑vitro test setups. That’s where our expertise elevates your simulation program.

At our facility, we design and execute targeted in‑vitro validation studies that provide the experimental data needed to build a robust, risk‑informed credibility case. Whether your model simulates hemodynamics, structural loading, fatigue behavior, or device–tissue interaction, we create controlled, reproducible test environments that generate the high‑quality data required for meaningful comparison.

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  • Physiologically Relevant Test Setups:
    Custom mock‑loops, anatomical models, and mechanical rigs engineered to replicate the conditions represented in your simulation.

 

  • Model‑Specific Validation Protocols:
    Experimental designs tailored to the model’s context of use, ensuring that validation data directly supports the credibility goals defined in V&V 40.

 

  • High‑Resolution Measurement & Imaging:
    Precision flow, pressure, displacement, and strain measurements — plus optical access for PIV, high‑speed imaging, or deformation tracking.

 

  • Traceable Data Integration:
    Rigorous documentation, uncertainty quantification, and data processing workflows aligned with the standard’s expectations for transparency and reproducibility.
  • Direct Comparison to Reality:
    In‑vitro setups provide controlled, repeatable conditions that allow clear, quantitative comparison between simulation predictions and physical behavior.

 

  • Risk‑Informed Evidence:
    Validation activities are scaled to the model’s decision impact, ensuring efficient use of resources while meeting regulatory expectations.

 

  • Regulatory Confidence:
    High‑quality experimental validation strengthens the credibility case and increases acceptance of simulation evidence in submissions.

 

  • Accelerated Development:
    Early alignment between computational and physical results reduces uncertainty, supports design optimization, and minimizes costly redesign cycles.

 

By combining advanced in‑vitro testing capabilities with a deep understanding of ASME V&V 40, we deliver validation evidence that is both scientifically rigorous and directly aligned with your model’s intended use. Partnering with us means your simulations are backed by experimental data you can trust — enabling safer devices, stronger submissions, and faster innovation.

Workflow

How we work:

A clear, three-step workflow—ensures a reliable, data-driven progress.

Feasibility
Study

Performance
Charaterization

Full approval-
relevant studies

Your journey with ac.biomed:

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1.
Service Request

2.
Information Provision

3.
NDA

1.
Service Request
2.
Information Provision
3.
NDA
4.
Service Requirements
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4.
Service Specification

5.
Quotation

6.
Order

7.
Order Confirmation
5.
Service Specification
6.
Quotation
7.
Order
8.
Order Confirmation
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8.
Test Plan

9.
Test Plan Approval

10.
Test Execution

11.
Test Report
9.
Test Plan
10.
Test Plan Approval
11.
Test Execution
12.
Test Report

Our strengths

“Outstanding service, reliable support, genuine customer closeness and open communication – this is our shared path to success.”

Quality

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We want to hear from you. Whether you‘re a prospective client, a professional interested in joining our team, or simply someone interested in our work, send us a note.

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