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Thrombogenicity

(Blood Pump)

Blood pumps are life-sustaining technologies, but their interaction with blood flow introduces a critical challenge: thrombosis. The formation of clots within or around the device can impair pump performance, increase hemolysis, and pose serious risks to patient safety. That’s why thrombogenicity testing is a cornerstone of blood pump validation.

At our laboratory, we provide specialized thrombogenicity evaluations designed to meet the unique demands of blood pump development:

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  • Simulated Physiological Conditions:
    Testing under clinically relevant flow rates, shear stresses, and pressure profiles to replicate clinical use.

 

  • Quantitative Metrics:
    Measurement of activated clotting time (ACT) and optical analysis of clot formation to assess the thrombogenic potential.

 

  • Design Optimization:
    Data-driven insights into impeller geometry, surface properties, and flow path design to minimize clot risk.
  • Patient Safety:
    Reducing thrombosis risk prevents complications such as embolism, stroke, or device failure.

 

  • Performance Assurance:
    Reliable pump operation depends on maintaining unobstructed flow without clot formation.

 

  • Accelerated Market Access:
    Demonstrating thrombogenicity control streamlines regulatory approval and builds confidence in the device safety.

 

By combining advanced test systems, expert analysis, and strict adherence to international standards, we help manufacturers validate the safety and reliability of their blood pumps. Partnering with us means confidence in compliance, innovation, and patient protection.

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

ac.biomed provides
quality services.

Certificate
ISO 17025
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Certificate
ISO 9001:2015
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Move forward
with ac.biomed

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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