With a fully integrated concept-to-commercialization solution, Veranex’s design and engineering expertise sets us apart, providing you with visibility to development feasibility and opportunity along the way.
Our expertise improves your launch readiness and expedites the development of your technology for regulatory and commercial success. We’re ISO 13485-certified and FDA-registered for medical technology product development, and with more than 30 years of experience and a global reach into emerging markets, our design and engineering specialization will make your MedTech vision a reality.
For Design & Engineering Specialization, Veranex Is Your Difference
Informing and inspiring solutions to improve outcomes
Unearth opportunities and identify risks to promote innovation and create a compelling and executable product vision. By asking the right questions at the start, we provide a comprehensive strategy to take you to commercialization.
- Contextual inquiry
- User needs identification
- Business and design strategy
- Concept generation
- Competitive and comparative landscape research
- Technology research and assessment
Moving toward a compelling, deployable solution
Our teams create and iterate prototypes, prove technical feasibility, and gather feedback to understand the user experience. We leverage human-centered industrial design, digital product design, and human factors expertise to translate research insights into product solutions and experiences. We all do this all with a focus on building a solid design history file with clinically relevant requirements, risk management, and regulatory strategy. Development activities include careful planning around budget and timing needs for the entire program — reducing investment risk.
- Requirements gathering
- Physical and digital prototyping
- Concept development
- UI story mapping
- Risk management
- Regulatory strategy
- Anthropometric research
- Participatory design
- User feedback sessions
We provide human factors engineering and usability engineering (HFE/UE) support and testing services to successfully meet the requirements of the FDA and IEC 62366. This includes usability engineering file planning and HFE/UE validation reporting. We also support design and testing of device labeling and packaging, as well as effective instructions for use and summative usability validation testing.
Arriving at a complete engineered design
Translate early concepts into focused, detailed, engineered solutions completed under design controls. Our experts integrate human factors engineering and human-centered industrial and digital design into fully functional, single systems suitable for usability and engineering evaluation. With necessary rigor, we also oversee risk management, user and design failure modes and effects analysis (FMEA) activities, engineering testing, and design verification planning — all leading to design freeze.
- Functional and manufacturable engineered design development
- Risk management activities
- Engineering verification prototyping
- Functional testing
- Human factors/usability evaluations
Design validation testing is a key component of the evaluation of medical device safety and performance and we provide analytical services to meet chemical, microbiological, biocompatibility, electrical, and mechanical testing.
Demonstrating a proven design
Ensure your product meets functionality, reliability, usability, and safety requirements through rigorous verification and human factors validation testing suitable for FDA, EMA, and other regulatory submission. We build production-equivalent devices using detailed manufacturing procedures, quality requirements, and a qualified supply chain. We also demonstrate that your designed device meets design input specifications.
- Production equivalent builds
- Design verification testing
- Human factors validation testing
Move your product toward launch with our world-class project, manufacturing, and quality teams. Our engineers oversee production, tooling development, and configuring manufacturing lines, followed by process validation, risk management, and failure modes and effects analysis (FMEA). From building and testing pilot units to assembly and design validation studies, we prepare and refine until it’s time for submission.
- Process validation
- Production-ready lines
- Risk management activities
- Design validation testing
- Regulatory submission
Our support continues after approval or marketing clearance. Our proven quality system, together with our highly experienced team, ensures that shipped devices and their device history records are complete and fully reviewed. As production volumes grow, we implement lean processes to drive cost reduction, improve reliability, and address rapid, response-to-market demands. Postmarket and user feedback support continuous improvement.
- Delivering product
- Sustaining engineering
- Postmarket evaluations
- Cost reductions
Your SaMD Solution
The FDA and other regulatory agencies are dedicated to advancing digital health products due to their ability to prevent, manage, mitigate, and monitor disease. From concept to commercialization, Veranex helps you design and develop mobile health devices, software as a medical device (SaMD), wearables, sensors, and more. Our innovative solutions evolve with technology and medicine and scale as your needs expand.
- Strategy design
- Design validation development