Medical Device Design, Development & Manufacturing
Transform your device from concept to approved and
manufacturing-ready.
Device Design & Development Services
Concept
Development
Quality
Support
Rapid
Prototyping
Low-Volume
Manufacturing
Working with Rev.1 Engineering
Design, development, and manufacturing under one roof.
Medical Device Development for Startups and OEMs
Early-Stage Innovators & Venture-Backed Startups
Established MedTech Brands & Commercial OEMs
Medical Device Development Across Clinical Fields.
Structural Heart
Gastroenterology
Electrophysiology
Cardiovascular
Oncology
First-of-Kind
Let's innovate together.
Rev.1 Engineering Case Study: Ablation Frontiers/Medtronic
The redesign slashed part count from 33 to 7 and saved nearly 5 hours of assembly time per unit, dramatically cutting COGS ahead of the company’s acquisition by Medtronic.
Medical Device Development From Concept to Manufacturing.
Engage Rev.1 at stage one or across the full development program, with engineering, quality and manufacturing support coordinated around device requirements.
- Concept Development: Rev. 1 refines initial ideas through early-stage architecture, user needs discovery, proof-of-concept modeling, and initial risk assessments to establish a feasible product path.
- Design & Engineering: The team builds out detailed mechanical, electrical, and software designs while establishing the Design History File (DHF) to ensure strict ISO 13485 compliance.
- Rapid Prototyping: Utilizing agile in-house techniques and soft tooling, Rev. 1 produces functional prototypes and bench-test models to rapidly prove out device performance.
- Verification & Validation: Formal design reviews, bench testing, and validation trials are conducted to generate objective technical evidence that the device fulfills all user needs and regulatory requirements.
- Manufacturing Transfer: Rev. 1 translates design outputs into complete Device Master Record (DMR) packages, detailed assembly instructions, BOMs, and tooling specs for seamless production handoff.
- Low-Volume Manufacturing: Operating within ISO-certified cleanrooms, Rev. 1 delivers pilot assembly runs, clinical trial lots, and early bridge production without requiring high-volume CDMO commitments.
We specialize in complex, first-of-kind medical devices—but that’s not all we do.
Take your catheter from concept to manufacturing.
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 manufacturing.
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 manufacturing.
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 manufacturing.
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.
What stages of medical device development can Rev. 1 support?
Rev. 1 supports every stage of the product lifecycle—from initial concept development and design engineering to rapid prototyping, verification & validation, design transfer, and low-volume cleanroom manufacturing.
Can Rev. 1 take over a device that is already in development?
Yes. You can engage Rev. 1 at any single development stage to solve a specific engineering bottleneck or rely on us across the remaining lifecycle to drive your project to completion.
Does Rev. 1 provide rapid prototyping in-house?
Yes, we maintain in-house prototyping capabilities—including 3D printers, CNC mills, lathes, braiders, laminators, and laser welders—to build and iterate physical working models quickly.
Does Rev. 1 offer low-volume medical device manufacturing?
Yes, we provide flexible, ISO-certified class 7 and 8 cleanroom manufacturing for pilot builds, animal studies, clinical trial lots, and early commercial bridge production without requiring high-volume CDMO commitments.
What types of catheter and minimally invasive devices does Rev. 1 develop?
Rev. 1 specializes in complex delivery catheters, structural heart devices, electrophysiology (EP) mapping and ablation tools, and cardiovascular delivery systems.
How does Rev. 1 support design for manufacturability (DFM)?
We integrate manufacturing and quality input early during concept and design to ensure your device is viable for manufacturing.