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.

53

%

Average error in pre-market commercialization timelines for medical devices¹

5

%

of medical device startups make it to market¹

35

YEARS of product development experience

800

+

disciplines collaborate for project success

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.

Our Quality Services

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.

Software Development Capabilities

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.

Our Testing Capabilities

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.

Manufacturing Solutions

Tony DiBella

Sr Director, Product Development Program Management

Matt Perry

VP, Programs and Process – PDE

Ann Meyer

Director, Systems Engineering

Stephany Esa, MSc.

Director, Design Assurance Engineering

pde-eng-case-1

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

pde-eng-case-2

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

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.

Testing and Prototyping

Testing_500x500

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.

Quality Services

Quality Consulting_Related Service Page_500x500

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.

Regulatory Services

Regulatory Consulting_Related Service Page_500x500

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.

Human Factors_500x500

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.

Partner with Veranex