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Outcome-Driven Solutions for Medtech Challenges

Breakthrough innovation requires more than great solutions; it demands deep expertise and insight. Veranex packages outcome-driven solutions with 25+ years of specialized knowledge across major medtech categories, delivering integrated capabilities that solve your most pressing challenges faster and with greater certainty.

Purpose-built solutions. Proven results. User & Patient-centered innovation.

 

Purpose-Built for Breakthroughs

Whether you're transforming patient care or disrupting entire therapeutic categories, innovation requires more than great science, it demands velocity.  Veranex was founded to bridge the gap between visionary concepts and market reality, combining proven expertise with agile execution to accelerate the innovations that matter most.  

We are the Innovation CRO.

Legacy of excellence. Proven execution. Patient impact accelerated.

 

Successful Design Verification Powered by Integrated Prototyping and Testing Expertise

Decades of expertise with prototyping and testing to de-risk development and accelerate your path to a successful submission.

A COMPELLING AND DEPLOYABLE SOLUTION

We treat prototyping and testing as a single function designed to generate verifiable proof, building a more robust device and a more defensible regulatory submission simultaneously. By co-locating our engineering, prototyping, and testing teams, we create a powerful engine of continuous improvement.  Allowing us to build, test, analyze, and refine in days, not months, to generate robust data needed to support design verification activities at every stage.

A device is only as strong as the evidence that supports it.

Critical Prototype and Testing Capabilities for Successful Design Verification

Our seamless feedback loop between prototyping and testing provides the evidence you need to de-risk and streamline development.

We create the physical tools you need to answer critical questions. Whether for early-stage feasibility, human factors studies, or rigorous benchtop testing, we select the right method to create a medical device prototype that generates meaningful data.

Our in-house capabilities include:

Additive Manufacturing

FDM, SLA, and PolyJet technologies for rapid creation of complex geometries and multi-material models.

CNC Machining

Precision-machined components in a wide range of medical-grade plastics and metals.

Urethane and Silicone Casting

Ideal for producing small batches of production-quality parts for extensive testing or early evaluation.

Assembly and Finishing

Complete assembly, fit modification, and finishing services to create fully functional test models.

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Rigorous Testing Services: Generating Evidence with Confidence 

  • Our ISO 13485-certified labs provide the data and documentation to prove your design performs as intended. We handle everything from standardized protocol execution to complex, custom analyses, ensuring the data is traceable, reliable, and submission ready.
  • Ensure your device is reliable and market ready:
    • Mechanical and Performance Testing:Characterizing performance under real-world physical forces
    • Electrical Safety & Performance: Verification against IEC 60601 standards and other critical regulations.
    • Environmental and Aging Simulation: Assessing device longevity and material durability.
    • Packaging and Sterilization Validation: Ensuring sterile barrier integrity and robustness.

Custom Solutions for Design Verification Challenges

Standard tests are not always sufficient for trailblazing devices. Our expertise extends to developing and validating novel test methodologies to assess unique performance attributes or use cases.

Custom Test Fixture Design

We design and build custom fixtures and equipment to replicate clinical use and isolate critical performance variables.

Test Method Validation

We develop and execute robust test method validation protocols, providing the objective evidence required by regulatory bodies to prove that a novel test method is accurate, reliable, and fit for its intended purpose.

Anatomical Model Development

We research, develop, and validate physiologically accurate test models that authentically replicate the anatomical environment. These surrogates, often incorporating real tissue in our BSL-II labs, are robust enough for both rapid design iteration and formal design verification efforts.

Case Studies

Driving Testing and Prototyping Innovation & Strategy

Real applications where our team accelerated a device design to improve use, performance, and functionality through utilization of our testing and prototyping services. 

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Related Services at Veranex

Quality Services

 

Our quality experts ensure you perform the most critical testing by starting with a robust risk assessment. We then confirm your test methods are rigorously validated in accordance with regulatory standards, creating a clear and defensible path to submission approval.

Quality Services

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Preclinical Services

 

Leverage our preclinical facilities and anatomical expertise to guide your test method development and refine your device design. Testing in a simulated clinical setting provides authentic, data-driven feedback, ensuring your device is optimized for real-world performance long before pivotal studies.

Preclinical Services

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Engineering and Development

 

Our integrated engineering and development teams are central to your project’s success. We combine decades of experience with creative, solution-oriented strategies to solve complex challenges, ensuring your project navigates technical hurdles efficiently and reaches submission readiness faster.

Engineering & Development

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Human Factors

 

From early usability models for formative studies to fully functional prototypes for validation, our teams provide the critical tools needed to guide user-centric design. We ensure your device is not only effective but also intuitive and safe for patients and clinicians.

Human Factors

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De-Risk Your Path to Design Verification

Move from concept to certainty. Our integrated prototype and testing services and expertise will help de-risk development, satisfy regulatory requirements, and accelerate your timeline to being market ready.