Business Details
19 Years
experience
Your Trusted Partner for Medical Device Development
Rev1 Engineering has been a trusted partner in medical device development since 2007, offering end-to-end solutions from concept to manufacturing. Our ISO 13485-certified processes ensure rigorous quality standards, while our cross-functional teams bring expertise in structural heart, gastrointestinal, oncology, and wearable device technologies. With a focus on innovation and manufacturability, we act as an extension of client teams, providing transparent communication and tailored strategies. Our state-of-the-art facilities in Temecula and Murrieta, California, support rapid prototyping and scalable cleanroom manufacturing. Decades of experience in complex, first-of-kind devices position us to de-risk development and accelerate time-to-market.We prioritize client collaboration, integrating engineering, quality, and regulatory compliance to meet project-specific goals. Our leadership team combines technical and operational excellence to guide over 200 MedTech startups and OEMs through successful product launches. By embedding design-for-manufacturing principles early, we ensure seamless transitions from prototype to commercialization. Client testimonials highlight our problem-solving agility and commitment to delivering life-saving technologies. Through continuous improvement and adherence to global standards, we maintain trust as a strategic development partner.
Services
Medical Device Development
Design Services
Concept Development
Quality Support
Rapid Prototyping
Strategic Manufacturing
Catheter Development
Guidewire Engineering
Smart Device Design
Wearable Technology
Details
- Year established: 2007
Highlights and features
- ISO 13485-certified processes ensure regulatory compliance and quality.
- Cross-disciplinary expertise in structural heart, GI, and oncology devices.
- Integrated engineering and manufacturing teams reduce development timelines.
- Rapid prototyping with in-house 3D printing and CNC machining capabilities.
- Client-focused IP ownership policies protect your innovations.
Associations and certifications
- ISO 13485:2016
What people say
High-quality work
Problem-solve
Market-ready faster
Delivered from cradle to market
Reduced part count
Services
Medical Device Development
We provide end-to-end medical device development for complex, first-of-kind innovations. Our services span concept validation, design engineering, and regulatory-ready manufacturing. Clients benefit from cross-disciplinary expertise in structural heart, vascular, and wearable technologies. ISO 13485-certified processes ensure compliance and quality from prototype to commercialization.
Rapid Prototyping
Our in-house prototyping capabilities include 3D printing, CNC machining, and laser welding. We enable fast iteration of complex components for MedTech startups and OEMs. Rapid prototyping reduces development risks and accelerates validation testing. Clients receive functional prototypes aligned with clinical and manufacturing requirements within tight timelines.
Strategic Manufacturing
We offer scalable cleanroom manufacturing in ISO Class 7 and 8 environments. Services include low-volume pilot production, clinical builds, and transition to full-scale manufacturing. Design-for-manufacturing principles ensure seamless scalability. Clients benefit from controlled quality systems and supply chain expertise for consistent, compliant device production.
Design Services
Our design team creates manufacturable solutions balancing innovation and technical precision. Services include mechanical design, materials selection, and usability optimization. We specialize in complex assemblies for catheters, guidewires, and capital equipment. Cross-functional collaboration ensures designs meet clinical needs and regulatory standards.
Quality Support
Quality support embeds compliance throughout device development. We provide traceable documentation, risk management, and validation protocols. Our ISO 13485-certified systems ensure adherence to FDA and global regulatory requirements. Clients receive controlled builds and audit-ready processes to streamline approvals and commercialization.
People
Scott Huter
CEO
Scott Huter leads Rev1 Engineering with over 25 years of MedTech leadership experience. He drives strategic growth while ensuring technical excellence and client satisfaction across medical device development projects.
Kevin Magrini
COO
Kevin Magrini oversees operations at Rev1 Engineering, focusing on process optimization and client delivery. With extensive experience in medical device manufacturing, he ensures efficient project execution and quality compliance.
Andy Denison
CTO
Andy Denison directs technical innovation at Rev1 Engineering. His expertise in complex device engineering and R&D drives breakthrough solutions for structural heart and wearable technologies.
Laura Herrera
VP of Quality
Laura Herrera leads quality assurance with a focus on ISO 13485 compliance. She ensures robust quality systems across development and manufacturing to meet global regulatory standards.
Dan Velasco
Director of Engineering
Dan Velasco manages engineering teams specializing in catheter systems and guidewires. His technical leadership ensures innovative, manufacturable solutions for challenging clinical applications.
Questions
Where is Rev.1 Engineering located?
Rev.1 Engineering is headquartered in Temecula, CA, with a cleanroom manufacturing facility in Murrieta, CA.
Who owns the intellectual property (IP) for developed devices?
Clients retain full ownership of all IP generated during development partnerships with Rev.1 Engineering.
What types of medical devices do you specialize in?
We specialize in structural heart, vascular, gastrointestinal, oncology, wearable, and first-of-kind medical devices.
Are your manufacturing processes ISO certified?
Yes, we maintain ISO 13485:2016 certification for our quality management systems in medical device development and manufacturing.
How does Rev.1 support device prototyping?
We offer rapid prototyping with in-house 3D printing, CNC machining, and laser welding for fast iteration and validation.
