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Capabilities

Medical device development

We specialize in minimally invasive, complex medical device development and manufacturing.

Rev.1 Engineering is a medical device development and manufacturing partner supporting startups and OEMs through concept development, prototyping, and low-volume production. Our team helps bring medical device ideas to life with practical engineering, clear documentation, and a focus on manufacturable design. Whether you’re validating early feasibility or preparing for the next phase of development, we provide hands-on support to move faster with confidence.
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Innovative Medical Device Design and Development Company Since 2008

Rev.1 Engineering is a medical device development company that specializes in end-to-end medical device development, offering a blend of advanced engineering and design. 

We prioritize quality and innovation, taking your idea from concept through finished device. ISO 13485:2016 Certified, Rev.1 Engineering is your partner for medical device product innovation. We offer:

  1. Experienced Engineering Team: Averaging over two decades in medical device development.
  2. Advanced Technology: Utilizing the latest in design, prototyping, and strategic manufacturing.
  3. 100% Customized Solutions: Tailoring development to meet specific project needs.
  4. Quality Assurance: Adhering to ISO 13485:2016 standards.
  5. Efficient Prototyping: In-house equipment and processes for rapid product development.

Contact us today to speak with an expert in device design & development.

Why Teams Choose Rev.1 Engineering

Medical device companies choose Rev.1 Engineering because we combine speed with engineering excellence. We’re structured to be agile—solving problems quickly and creatively—while still keeping quality standards at the center of the development process. Our goal is to help teams move forward with confidence, knowing the design is grounded in real-world engineering and manufacturing requirements.

If you’re looking for a medical device development partner that can help you move from idea to functional prototype—and support low-volume builds as your program evolves—Rev.1 Engineering is ready to help.

Rev.1 Engineering's

Quality 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.
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Learn about working with Rev.1 Engineering.

Our integrated approach combines engineering, quality, and manufacturing expertise to ensure a seamless transition from idea to market-ready product. Whether you're developing a first-of-kind innovation or refining an existing platform, we act as an extension of your team.

Start Developing Your Medical Device

Rev.1 Engineering can help take your device from concept to approval with our innovative solutions for complex medical device technologies.

Device Development and Prototyping

Are you looking for prototype development? Rapid 3-D printing?

Our team combines expertise in mechanical and electrical engineering to turn groundbreaking concepts into fully functional prototypes.

Our hands-on, collaborative approach speeds up the product development process and smooths the transition to commercialization, making us a go-to partner in medical device innovation.

Full-Service Medical Device Development

We're a full-service development company supporting medical devices since 2008. Learn more about our design and development services.

Strategic Manufacturing

Meet crucial development milestones, such as V&V, animal studies, and regulatory clearance without needing to find a full-scale contract manufacturer.
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Prototyping

Rapid prototyping is vital in the development process, facilitating innovation through immediate feedback and modifications.
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Bench Testing

An important aspect of the development process, bench testing allows us to test devices in a simulated environment.
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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.
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Cutting-Edge Facilities Designed for Innovation

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.