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Turn Vision into Velocity with the Innovation CRO

Traditional CROs fragment device development with costly hand-offs and learning curves. Veranex unites the essential disciplines for medical device & diagnostic development under one roof from sketch to evidence-generation to market launch.

All connected. All aligned. All accelerating your path to market—delivering breakthrough devices and diagnostics that improve patient lives sooner.

Explore our Services

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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.

 

Solutions

Expertise

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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.

 

Explore our Company

Digital Health Solutions

Accelerate your digital health technologies from concept to commercialization with an integrated partner built to improve patient outcomes and enhance efficiency. 

Navigate the Evolving Digital Health Landscape

Companies that prioritize design have outperformed the S&P 500 by 228% over a 10-year period.


Digital health uses information and communications technology to manage illness, promote wellness, and improve patient outcomes. The landscape is transforming rapidly, with the evolution of Artificial Intelligence (AI) and Machine Learning (ML) enabling more sophisticated and powerful systems than ever before. However, this innovation brings new complexities in development, cybersecurity, and regulatory requirements. Veranex provides the integrated expertise to help you navigate this pathway, ensuring your digital health technologies are safe, effective, and commercially successful.

Source: Sheppard, B., Sarrazin, H., Kouyoumjian, G., & Dore, F. (2018, October 25). The business value of design. McKinsey & Company.

A Strategic Approach to Digital Health Consulting

We believe a clear strategy is the foundation for success in the complex world of digital health. The traditional, fragmented approach of handing off your innovation between separate vendors costs time and adds risk. As the industry’s first Innovation CRO (iCRO), Veranex acts as your single, unified partner. Our expert teams consult across the entire product lifecycle, helping you navigate the pathway to market with confidence and clarity. We provide the strategic guidance needed to make smarter decisions, compress timelines, and de-risk your investment. 
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Define Your Digital Health Strategy for Regulatory Success

A successful regulatory submission for digital health technologies begins with a well-defined strategy. Our regulatory consultants help you navigate the complex global landscape to establish the most efficient path to market.

Our submission support includes:

  • Regulatory Strategy: We define the optimal regulatory pathway for your product, including for Software as a Medical Device (SaMD) and AI/ML-enabled devices.
  • Device Classification: We provide expert guidance to confirm the classification of your device within the evolving regulatory framework—a critical first step that informs your entire strategy. 
  • Policy Navigation and Gap Analysis: We help you navigate FDA and Notified Body policies, performing gap analyses to provide clear, actionable guidance for your development and execution planning. 
  • Clinical Evaluation: We assess and assemble the clinical evidence needed to demonstrate the safety and efficacy of your digital health technology, a critical and often challenging requirement for novel solutions. 
  • Submission Support: We provide hands-on support for interactions and submissions with the FDA and international notified bodies. 
Our Regulatory Services

Master the Evolving Digital Health Technology Landscape

Keeping your team current with the latest standards and regulatory shifts is essential for success. We offer expert-led training that clarifies the complexities of the digital health landscape. You can access our previous sessions on-demand or partner with us to develop a custom training program tailored to your team's specific challenges and goals.

Training Solutions

Engineer Robust Digital Health Technologies

Our product development and engineering teams bring your digital health solutions from concept to reality, with quality assurance integrated at every step. We have deep experience developing a wide range of sophisticated digital health technologies and ensuring they meet both user needs and stringent regulatory standards. Our approach prioritizes a strong user experience (UX/UI) to improve adoption and reduce use-related risks.

Our key development areas include:

  • Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)
  • Cybersecurity and data protection strategy implementation
  • Software architecture and system functions
  • Cloud-based data systems and Health IT
  • Wireless medical devices and interoperability
Software Development Services
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Rigorous Quality Assurance Delivers Reliable Digital Health Solutions

Our quality assurance services are woven throughout the development lifecycle to ensure your digital health solution is safe, reliable, and compliant. We provide integrated risk assessments from initial planning through final verification and validation, ensuring potential issues are identified and mitigated early. This proactive approach reduces rework and ensures a smoother path to market.

Our testing strategy and consultation services include:

  • Integrated software and hardware risk assessments
  • Verification and validation testing
  • Consultation on specialized testing requirements for EMC, device interoperability, and more.
Testing Capabilities
Quality Services

The Innovation CRO for Your Digital Health Solutions

Veranex constructs customized cross functional teams, integrated into one project to support your project's dynamic and challenging solutions to reduce burden for you and accelerate success. 

Case Studies

Real-World Impacts at Veranex

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AI-Driven Design Strategy

 

Situation

A client sought to optimize Multiple Sclerosis (MS) treatment by creating an AI-driven digital health tool for MRI analysis. They faced challenges with inconsistent clinical protocols and lacked a clear product, access, or regulatory strategy to guide development and ensure adoption.

Successes

  • Defined a clear product and regulatory strategy for a minimum viable product (MVP) analysis and reporting tool, creating a feasible, data-driven starting point.
  • Developed a comprehensive product roadmap to guide the digital health technology from MVP to its long-term "North Star" vision, ensuring a scalable and future-proof design.
  • Identified key market access factors, including billing, data requirements, and tech maturity, to create a holistic digital health strategy that supports successful adoption.

 

Services by Veranex

  • SW Development
  • Research and Strategy
  • Product Design
  • Program Management

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Digital Health Surgery System Development

 

Situation

A client needed to modernize their 20-year-old Endoscopic Cyclophotocoagulation (ECP) surgery system, which relied exclusively on physical knobs and buttons. The challenge was to transform the analog device into a digital health platform by developing an intuitive digital interface that could streamline workflows and enhance usability.

Successes

  • Replaced the system's physical controls with a modern, touch screen interface that optimized usability, provided access to logs, and streamlined clinical workflows.
  • Developed a user-focused digital experience by creating a secondary, articulating screen, ensuring all users could easily view and access critical information during a procedure.
  • Provided end-to-end software development support, which included creating a 140-page UI Style Guide and managing software integration to bridge the gap between design intent and the final interface.

 

Services by Veranex

  • SW design & development
  • Quality Design Assurance
  • UX / UI design & development
  • Human Factors
  • Program Management
  • Prototyping Shop

Get Expert Support for Your Digital Health Solutions

Building the future of healthcare requires a partner who understands the entire ecosystem and complexities around the evolving digital health landscape. Veranex is more than a consultant; we are a dedicated extension of your team working towards your success. 

Partner with us Today