Medical Device Development Company: Take Your Idea from Concept to Completed.
Learn about working with Rev.1 Engineering.
Design
Services
Concept
Development
Quality
Support
Rapid
Prototyping
Strategic
Manufacturing
More than one medical device specialty.
Comprehensive MedTech expertise that delivers.
Structural Heart
Gastroenterology
Electrophysiology
Cardiovascular
Oncology
First-of-Kind
Let's innovate together.
The Rev.1 Engineering Medical Device Development Quality Promise.
Taking your device through the full product lifecycle.
We specialize in complex, first-of-kind medical devices—but that’s not all we do.
Take your catheter from concept to manufaturing.
Take your catheter from concept to manufacturing with an experienced partner in medical device development. We support you through every phase—concept refinement, design for manufacturability (DFM), rapid prototyping, design verification and validation (DV&V), and risk analysis. Our cross-functional teams integrate engineering, quality, and regulatory considerations early to streamline the path to manufacturing.
Our ISO 13485-certified processes, robust quality systems, and supply chain expertise ensure consistent, high-quality production that meets your technical and regulatory requirements.
Take your smart device from concept to manufaturing.
From early concept development to DFM and rigorous design verification, we help ensure your device is optimized for functionality, reliability, and manufacturability. Our team focuses on the physical build—integrating sensors, electronics, and enclosures—while aligning with your broader digital ecosystem.
We specialize in taking complex electromechanical systems from prototype through production with precision and speed. Our ISO 13485-certified processes ensures your smart device is built to meet regulatory standards and performance expectations—at every stage of development and manufacturing.
Take your wearable from concept to manufaturing.
Developing wearable medical devices requires a unique balance of comfort, durability, and clinical performance. We support you from early-stage concepting through DFM, prototyping, and system integration—focusing on miniaturization, ergonomics, and biocompatibility. Our teams ensure the device is engineered for continuous wear, patient safety, and reliable data capture.
With expertise in low-profile assemblies, flexible materials, and integrated electronics, we help you bring complex wearable technologies to life. Our ISO 13485-certified processes and end-to-end development capabilities streamline the path from prototype to scalable manufacturing—ensuring your device is ready for clinical and commercial success.
Take your equipment from concept to manufaturing.
We support the development of capital equipment from concept through manufacturing, with a focus on complex assemblies, precision components, and system integration. Our team brings deep expertise in mechanical design, electromechanical systems, and DFM to help you move efficiently from prototype to production.
With ISO 13485-certified processes and robust quality controls, we ensure your equipment meets performance, safety, and regulatory requirements—whether you’re building diagnostic platforms, surgical systems, or therapeutic devices.
Medical device development and manufacturing.
From delivery systems and handheld tools to single-use components and diagnostic accessories, we support a wide range of medical device types. Whether your project involves miniaturization, complex assemblies, or custom materials, our team brings the technical depth to solve tough engineering challenges.
No matter the device category, our approach stays the same: integrated development, ISO 13485-certified processes, and a focus on quality, speed, and scalability. If it needs to be built—precisely and reliably—we’re ready to help.
Trusted by over 200+ medical device startups and OEMs.
See what our clients say.
Frequently asked questions.
Where are you located?
Rev.1 Engineering is headquartered in Temecula, California. This location acts as the center for innovation and general business activities. The Murrieta, California location, situated within a five-minute drive to our headquarters, hosts our 2,000 sqft cleanroom and strategic manufacturing facility.
Who owns the IP?
All IP generated while working with Rev.1 Engineering is owned by the client.
What does it look like to work together?
We work as an extension of your team—not just a vendor. Expect clear communication, regular check-ins, and a partnership built on trust and transparency.
Our dedicated teams move fast, so keeping your side of the project on track is key to avoid delays. Everything is laid out in a clear contract ahead of time, and we’re always transparent about timelines, budgets, and progress.