Your Experts in Medical Device Product Development and Engineering
Deep knowledge with an innovative approach that ensures your device is submission ready and will make a difference for patients on the market.
Your Partner in Medical Device Product Development Excellence
Our experienced medical device engineering teams provide the knowledge needed to set realistic expectations and navigate potential roadblocks effectively. We understand the intricacies of the development process, constantly monitoring for risks and ensuring that execution aligns with a clear, achievable plan.
Average error in pre-market commercialization timelines for medical devices1
of medical device startups make it to market1
YEARS of product development experience
disciplines collaborate for project success
1: Nocturnal Product Development. (2024, January). Nocturnal milestone based pricing 90 sec [Video].
What Clients Say
“Since we launched our redesigned TAVR delivery system, which was led by Veranex’s design and engineering teams, we’ve seen that the performance of the valve itself has improved.”
By R&D Director, Large Medtech
What Clients Say
“If it wasn’t for the Veranex team and their ability quickly adjust processes and staff we would have missed our first major milestone for this development program”
Sr Program Manager from a Large Strategic
What Clients Say
"Thanks again, the trip was absolutely worth it! I enjoyed the very interactive discussion and hands on suturing (and the impressive real time CAD adjustment by the team!) This really pushes us much closer to that finish line. Appreciate everyone’s contributions, and looking forward to the next steps."
Chief Pediatric General Surgery at major Hospital
Expert Medical Device Engineering Services to Advance Your Product Development
Transform your innovative product concept into a tangible, reliable device ready for market launch.
Veranex’s design process utilizes design controls per ISO 13485 ensuring your resulting product will meet both customers and regulatory demands. Our integrated teams of expert engineers utilize their experiences across various therapy and device areas to efficiently navigate executing detailed design activities through verification testing. We partner closely with you to provide regular updates and navigate critical decisions informed by the team’s assessments of risks or opportunities to help achieve your goals faster.
Build on a Foundation of Quality: your QMS Advantage
By integrating our expertise early and providing input with the final regulatory submission in mind, our integrated systems and design assurance engineers proactively minimize risk and set up requirements for easier verification and validation. This collaborative approach helps maintain your timeline and scope, avoiding costly delays down the line. Plus, our customizable QMS allows us to augment what you have or don't have, providing precisely the level of support your project needs.
Powering Your Device with Expert Software Engineering
In today's landscape, software is often at the heart of medical devices. We provide high-quality software engineering solutions for everything from safety-critical systems to connected applications. This crucial expertise ensures your device functions reliably and meets the complex demands of modern healthcare.
Verify Performance with Confidence: Rigorous Testing
Rigorous testing is how you minimize design or use-related risks and ensure your device performs as intended. Veranex's testing services are designed to do just that. We handle everything from test method development and validation to execution, under our ISO 13485 certified QMS. We work collaboratively to verify your design, generating traceable data, and effectively summarize into submission ready documentation.
Integrated Manufacturing Support: De-risking Your Path to Production
We engineer your design for assembly and commercial manufacturing success. By narrowing specifications and incorporating supplier input early, we finalize detailed design documentation that ensures your product can be reliably produced. This transforms your concept into a robust, manufacturable product. Veranex's experience in managing the complexities of product development with vendor collaboration means a streamlined path to finalize design details and to production.
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Meet the Team
Partner with Our Leaders Who Will Guide Your Product To Market
Tony DiBella
Sr Director, Product Development Program Management
As a Senior Director of Product Development Program Management, Tony orchestrates Veranex’s diverse engineering teams across mechanical, electrical, firmware, software, and systems disciplines, ensuring cross-organizational excellence and consistency. With nearly two decades of medical device development experience, he is a proven leader who expertly guides multidisciplinary engineering teams through complex projects while serving as a trusted technical advisor and liaison to clients, all while adhering to stringent FDA 21 CFR 820 and ISO 13485 quality system requirements. Tony's leadership delivers cohesive and compliant product development outcomes for your critical medical device innovations.
Matt Perry
VP, Programs and Process – PDE
As VP of Programs and Process, Matt Perry brings over 20 years of expertise in medical device development, with a proven track record guiding products from early customer research through to manufacturing and market release. His extensive background includes successfully leading the design, development, and manufacture of complex surgical devices through clinical studies and managing a diverse range of projects from high-volume disposables to electro-mechanical capital equipment. Matt's leadership ensures streamlined processes and successful program execution, delivering impactful medical device solutions for your business.
Ann Meyer
Director, Systems Engineering
As Director of Systems Engineering, Ann Meyer leverages over two decades of medical device development experience to create and implement achievable technical strategies that bring high-potential, trailblazing healthcare products to life. Her deep understanding of FDA 21 CFR 820 and ISO 13485 requirements, combined with her skill in championing customer needs and fostering an innovative team culture, ensures your project benefits from robust, compliant, and market-leading solutions. Ann's leadership in systems engineering is pivotal in translating complex challenges into successful, impactful outcomes for our clients.
Stephany Esa, MSc.
Director, Design Assurance Engineering
As Director of Design Assurance Engineering, Stephany Esa leverages over 11 years of expertise to ensure your complex medical device meets the highest standards of quality, safety, and regulatory compliance. Her leadership in risk management, Design History File documentation, and adherence to standards like ISO 13485 and FDA 21CFR820 is crucial for successful design transfer to manufacturing and sustained post-launch quality. Stephany's meticulous approach and extensive experience guide Veranex teams in delivering robust and compliant solutions that achieve market success.
Case Studies
Diverse Medical Device Development Experience
Agile Development of Large Medical System
Situation
A client needed the design finalized for and verified for a complex capital system that would run for up to 28 continuous days and interact with 20 disposables for operation.
Successes
- Completed development of 3 critical life support controls within the one system: Extracoporial membrane oxygenation (ECMO), fluid and air temperature, and continuous flow or sterile simulated biofluid
- Developed, refined, and verified 13 PCBs and 100’s of unique cable harnesses
- Completed the development of a high-risk medical device software and an alarm systems
Services by Veranex
- Early discovery and user research
- Product design ideation and refinement
- Rapid prototyping and testing
- Human factors and usability testing
- Pre-Clinical studies
- Software and UI Development
- Program Management
Concept to Successful Launch
Situation
Improve ease of use by designing and developing a mechanical veinous thromboembolism device that leverages existing system accessories.
Successes
- 84% reduction in use errors from on-device and product labeling was demonstrated via a usability formative study with healthcare professionals.
- The Veranex team supported the handle, packaging, and labeling design and development along with sourcing the system accessories to combine into a final kit.
- Strategically optimized and compiling robust DHF for expedited 510(k) submission to be within 1 year from project kickoff.
Services by Veranex
- Early discovery
- Product design ideation
- Rapid prototyping and testing
- Human factors and usability testing
- Product design refinement
- Manufacturing
Discover More
Related Services at Veranex
Testing and Prototyping
Ensure your innovative design performs flawlessly and meets critical standards. Our comprehensive testing services are backed by dedicated facilities and advanced equipment, allowing us to assess any product type with various levels of rigor.

Quality Services
Build quality into your medical device from the ground up. Our integrated quality services are essential for navigating complex requirements and ensuring your product is developed to the highest standards for a safe and effective device.

Regulatory Services
Navigate the complex regulatory landscape with confidence. Our regulatory experts are integrated into your product development process, providing the strategic guidance needed to anticipate requirements and streamline your path to approval.

Human Factors
Design intuitive and safe devices that truly meet user needs. Our human factors expertise is critical in product development for ensuring your device is designed around the user, minimizing risk and enhancing the overall experience for patients and practitioners.

Medical Device Engineering Services Focused on Outcomes
Successful product development is achieving key deliverables for regulatory submission so your product can reach the market and improve patient’s lives.
Our approach is centered on providing a breadth of experience and solution-oriented strategies to navigate technical and procedural complexities, ensuring your product is developed efficiently and positioned for its intended use.



