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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.

 

Your Trusted Partner in Full-Lifecycle Medical Device Software Development

Expert software and digital interface design and development services for both intricate Software in a Medical Device (SiMD) and innovative Software as a Medical Device (SaMD).

Our Integrated Medical Device Software Development Process

Comprehensive medical device software development expertise for both Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD) per IEC 62304 and ISO13485.

Our approach is powered by an experienced software team and expert UX/UI design specialists, who integrate into our project teams all the way from early phase concepting to ensure your device is a success. 

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This risk underscores why the early discovery and innovation phases are critical.  

Our integrated design teams focus on meticulously pinpointing market demands and critical user needs from the very beginning. This ensures the selected technologies and medical device software design are optimized for clinical utility and a distinct competitive advantage. 

By providing actionable insights upfront and fostering early collaboration with software developers to understand technical constraints, we guide the most effective design and development approach for a truly user-centered product and a smooth transition into development.

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Ensure your medical device software is built right from the start.

Embedding proactive quality assurance and risk management throughout the entire medical device software design and development lifecycle is essential, not just a final check.

This approach minimizes late-stage surprises, supports regulatory compliance (IEC 62304, ISO 13485) for all software classifications, and results in safer, more reliable medical device software.

Our in-process QA includes:

  • IEC 62304 & ISO 13485 Compliant Processes
  • Agile Quality Management & Iterative Reviews
  • Detailed Design Documentation
  • Requirements Traceability Analysis
  • Software Risk Management
  • Structured Code Reviews
  • Robust Configuration Management
  • Design Controls for all Software Deliverables

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Costly effective development with refined requirements and a clear development pathway.

Utilizing strategic requirements tracing ensures all functional, safety, and regulatory requirements for a safe and effective device are thoroughly defined and understood from the outset. Our cross functional integrated teams, allows us to efficiently execute with parallel development where appropriate, and the critical prioritization of high-risk components to safeguard your timeline and budget.

Explore our integrated engineering and development services. 

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Software architecture is critical to ensure functionality today but also adaptability and scalability for the future.

Our architects create resilient, secure, and high-performance blueprints tailored for the unique needs of medical applications, considering factors like data flow, security protocols, and platform choices relevant to your specific product.

What we deliver:

  • Scalable & Modular Architecture for SiMD and SaMD
  • Seamless System & Data Integration
  • Performance-Optimized & Efficient Design
  • Security & Compliance by Design (FDA, HIPAA, GDPR)
  • Strategic Technology Stack Selection

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We specialize in bringing sophisticated hardware-software interactions to life for SiMD in demanding embedded environments and developing robust applications for SaMD.

Our engineers translate your complex medical device requirements into precisely functioning, high-integrity software. We ensure reliable operation for both embedded SiMD and application-based SaMD solutions to directly support effective treatment, accurate diagnostics, and ultimately, patient safety. 

Our capabilities include:

  1. Embedded Firmware Development
  2. Embedded Application Development including Graphical User Interfaces (GUI)
  3. Accessory Application Development
  4. Real-Time Operating Systems (RTOS) Implementation including Embedded Linux Customization
  5. Complex Algorithm Implementation & Optimization
  6. Secure IoT & Cloud Connectivity
  7. Cybersecurity Solutions
  8. Manufacturing & Test Fixture Software 

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Ensure safe and compliant medical device software with exhaustive testing and verification.

This critical phase provides objective evidence that your software meets all specified requirements and performs precisely as designed in every anticipated use case, forming a key part of your regulatory submission.

Our testing & verification services include:

  • Comprehensive Test Planning and Protocol Development
  • Unit Verification (Unit Testing, Static Analysis, and Code Inspections)
  • Integration Testing
  • Software Verification Testing including Automated & Manual Test Execution
  • Regression Analysis & Testing
  • Performance, Load & Stress Testing
  • Software Anomaly Investigation & Reporting
  • Formal Verification Reporting (for submissions)

Check out our other quality assurance services

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Achieving an optimal user interface requires a deeply collaborative and iterative approach.

Our UX/UI team works closely with your stakeholders and our engineering teams, utilizing tools like Figma and Miro to

  • Translate insights into design solutions
  • Map out user journeys
  • Develop detailed wire frames
  • Construct interactive prototypes
  • Establish comprehensive component libraries

This ensures that your medical device user interface design is built on a foundation of clear communication, user feedback, and a shared vision for an intuitive and effective product.

Meet the Team

Meet Our Innovators in Medical Device Software Development

Shaping patient-centric medical device software design with intuitive UX/UI. Learn how their expertise accelerates innovation and ensures your project's success.

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Jesse Gibson

Director, Software Engineering
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Norb Gravelle

Sr Principal Software Engineer
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Tim Receveur

Sr Principal Software Architect
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ShweThee Kale

Manager, UX / UI Design

Case Studies

Real World Impact at Veranex

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Related Services at Veranex

Regulatory Services

 

See how our regulatory team can support your submissions, develop effective multi-region strategies, and provide ongoing consulting for a successful market launch.

Regulatory Services

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Quality Design and Manufacturing

 

Discover how our comprehensive quality services help you confirm your design and manufacturing approach, reducing risks and ensuring reliability from concept through scaled production.

Quality Design and Manufacturing

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Testing and Prototyping

 

Transform your software concepts into tangible, testable prototypes. Explore our advanced prototyping and testing capabilities to gain critical user feedback and design verification data throughout development.

Testing and Prototyping

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Human Factors

 

Ensure your innovative software translates into intuitive, safe, and effective user experiences. Explore how our human factors services.

Human Factors

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Innovate & Lead with Veranex: Expert Medical Device Software Development

Veranex has the expertise to deliver secure and high-performing embedded SiMD or standalone SaMD software to boost user acceptance and position your device as a market leader.

Partner with us to ensure your medical technology meets all standards and achieves its full clinical and commercial potential.