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.
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.
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
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.
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
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:
- Embedded Firmware Development
- Embedded Application Development including Graphical User Interfaces (GUI)
- Accessory Application Development
- Real-Time Operating Systems (RTOS) Implementation including Embedded Linux Customization
- Complex Algorithm Implementation & Optimization
- Secure IoT & Cloud Connectivity
- Cybersecurity Solutions
- Manufacturing & Test Fixture Software
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
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.
What Clients Say
"I like how simple and minimalist our design is, Steve Jobs would be proud"
Project Lead from Medtech Company
What Clients Say
"We were truly impressed with Veranex's UX/UI design for our capital system's display. They transformed a complex system into a remarkably approachable and intuitive interface, ensuring it's easy to use for nurses across diverse dialysis facilities. The design solution they created is subtle yet powerful, positioning us to be an industry leader in the future."
Director from Dialysis Equipment Company
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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.
Jesse Gibson
Director, Software Engineering
As Director of Software Engineering, Jesse Gibson brings over 18 years of proven leadership in developing impactful healthcare and life-science products, specializing in complex embedded systems compliant with ISO 13485 and IEC 62304. His process-focused mindset and extensive experience successfully guiding multiple medical devices through the full design lifecycle, including verification, validation, and clinical trials, ensure your project benefits from rigorous quality, regulatory adherence, and on-time delivery. Jesse's passion for creating solutions that make a difference, coupled with his empathetic customer leadership, positions him to drive your software development initiatives to successful market launch.
Norb Gravelle
Sr Principal Software Engineer
Norb Gravelle, a Sr Principal Software Engineer, leverages over 20 years of experience, including a decade dedicated to leading software development for Class II and III medical devices, to ensure robust and innovative solutions for your project. His expertise spans the entire product lifecycle, from initial innovation and planning through to mass production, marked by strong collaboration with multidisciplinary teams and a deep understanding of quality systems like FMEA and CAPA. Norb’s leadership ensures your software development is strategically aligned with manufacturing needs and regulatory demands, fostering successful and compliant product outcomes.
Tim Receveur
Sr Principal Software Architect
Tim Receveur, Sr Principal Software Architect, draws on 18 years of developing cutting-edge medical products for industry leaders, successfully delivering dozens of projects, including seven full new product developments from concept to launch. His extensive experience leading diverse teams and tackling complex challenges, enhanced by his proficiency in applying data science and machine learning to sensor data, allows him to architect innovative and effective solutions tailored to your specific needs. With over 150 patents, Tim's inventive approach and deep understanding of the medical device landscape will be pivotal in transforming your product vision into a successful reality.
ShweThee Kale
Manager, UX / UI Design
As Manager of UX/UI Design, ShweThee Kale champions a human-centered approach, ensuring the user experience intent is meticulously maintained from early-phase design through to late-phase development for your product. Her collaborative leadership across multidisciplinary teams results in empathetic, meaningful, and impactful solutions that effectively mitigate risk and enhance usability. ShweThee’s expertise in comprehensive UX/UI design, including critical labeling and IFU development, guarantees that your solution will not only meet user needs but also communicate safety and efficacy clearly, contributing directly to your project's success.
Case Studies
Real World Impact at Veranex
Integrated System Development
Situation
Veranex was to develop a next-generation ambulatory infusion pump system, complete with accessories and disposables, capable of performing reliably in both demanding clinical acute care and dynamic ambulatory settings.
Successes
- User-Centric Design Inputs: Led research translating diverse user needs (clinicians, patients) and challenging environments (acute, ambulatory) into robust software and medical device user interface requirements.
- Full Ground-Up System Development: Engineered a complete custom solution with a unique pump, disposables, embedded software, and full digital user experience for the medical device software development.
- Ensured Seamless Hardware-Software Cohesion: Achieved harmonious integration of embedded software, the digital interface, and all physical components for a reliable, intuitive user experience.
Services by Veranex
- Research and Strategy
- UX / UI
- Product & SW Development
- Quality assurance and engineering
Robotic Surgical System: Agile Software Development
Situation
A medical technology innovator envisioned a smaller, less expensive, and nimble single-port robotic surgical system, portable between operating rooms, to transform minimally invasive procedures.
Successes
- Strategic "Divide and Conquer" Implementation: Deployed an agile strategy to tackle complex software by developing distinct subsystems in parallel, maximizing efficacy.
- Accelerated Development Cycles: Leveraged rapid prototyping and simulated modeling to significantly increase development speed and enable early design verification.
- Robust & Integrated Architecture: Delivered a scalable software architecture suited for a sophisticated, next-generation robotic system, mitigating risks.
Services by Veranex
- Research and strategy
- Industrial Design & Engineering
- Human Factors
- UX / UI
- Software Development
- Quality Assurance
Discover More
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.

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.

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.

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

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.



