Medical Device Engineering Company in Southern California – ISO 13485 Certified

Expert medical device engineering for startups and OEMs — from concept through manufacturing. We deliver safe, compliant, and innovative Class II & III devices with speed and precision.

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Medical Device Engineering Firm Since 2008

Rev.1 Engineering is a full-service medical device engineering firm specializing in end-to-end product development. From concept design to rapid prototyping and scalable manufacturing, our experienced team helps startups and OEMs bring first-of-kind devices to market. ISO 13485:2016 certified, we prioritize regulatory compliance and innovation at every step.

Experienced Medical Device Engineers: 20+ years average experience in device development.
Advanced Prototyping & Design Technology: In-house equipment for fast iteration and testing.
Custom Engineering Solutions: Tailored to specific device requirements and project goals.
Regulatory Expertise: Deep knowledge of FDA and ISO 13485 compliance.
Concept-to-Commercialization Support: Seamless transition from R&D to cleanroom manufacturing.

Our Medical Device Engineering Promise

“Rev.1 Engineering brings our customers’ true needs and requirements to life through partnership, robust engineering principles, and state-of-the-art technologies. Our product quality will exceed customer expectations. Through our dedicated commitment to continuous improvement and regulatory compliance, we and our customers will be assured and confident to use our products with someone we love.”

Transform your device concept to approved &

manufacturing-ready.

Explore Capabilities

Design
Services

We create manufacturable designs that balance innovation, usability, and technical precision.

Concept
Development

Our team helps shape early ideas into validated, development-ready concepts.

Quality
Support

We ensure quality is embedded throughout the build process with traceable documentation and controlled execution.

Rapid
Prototyping

Quickly move from design to physical prototypes with fast, reliable, in-house builds.

Strategic
Manufacturing

Scalable cleanroom manufacturing tailored for early-stage needs and smooth transfer to full production.

Cutting-Edge Facilities Designed for Prototyping & Product Engineering Solutions

The Murrieta, California location, situated within a five-minute drive to our headquarters, hosts our 2,000 sqft cleanroom and strategic manufacturing facility. This cleanroom can meet the standards for both a Class 7 and Class 8 cleanroom environment.

This locations hosts our team of Assemblers, Quality Control Specialists, Manufacturing and Quality Engineers, and Technicians.

Our headquarteres in Temecula, Ca acts as the center for innovation and general business activites. Here, we focus on providing our customers with medical device design and development services with our team of Program Managers, Engineers, Technicians, and office staff.

Our Program Managers work with our clients during their weekly meetings from our headquarters office so they have easy access to both D&I and the Strategic Manufacturing Facilities.

Trusted by over 200+ medical device startups and OEMs.

See what our clients say.

We’ve partnered with hundreds of startups and established OEMs to bring breakthrough medical technologies to life. Our clients count on us for deep technical expertise, transparent communication, and a proactive approach that keeps projects on track and built for success.

From early feasibility to small-scale production, we’re proud to be the go-to development and manufacturing partner for innovators across the industry.

View Case Studies

VARTAN GHAZAROSSIAN

ABLATIVE SOLUTIONS

"Their high-quality work and ability to problem-solve allowed us to get our life-saving product market-ready faster than we originally projected.”

ART TAYLOR

TOPERA MEDICAL

"[Rev.1] delivered from cradle to market, taking on the entire project from the get-go to approval and transition to manufacturing."

ABLATION FRONTIERS

ACQUIRED BY MEDTRONIC

Our approach reduced the part count from 33 to 7, and decreased assembly per device time by nearly five hours. Ablation Frontiers was acquired by Medtronic in 2009.

Frequently asked questions.

Here are some of the most common questions we get from startups and OEMs navigating medical device development and manufacturing. If you don’t see what you’re looking for, feel free to reach out — we’re here to help.

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 with an engineering partner?

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.

Let's innovate together.

Connect with our medical device experts to kickstart your project! We specialize in minimally invasive, complex devices—but that’s not all we do. Our team has the expertise to support a wide range of medical device innovations.

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