Engineering, prototyping & regulatory planning to bring innovative medical devices from concept to market.
We specialize in early-stage, compliant clinical production — the critical bridge between product development and full-scale commercialization.
FDA-registered contract manufacturing & box-build assembly for pilot runs and scalable medical device production.
HDA creates innovative lifesaving and life enhancing products for medical startups and leading medical device manufacturers. We have been developing medical devices since 1982. In that time we have helped our startup clients create hundreds of millions of dollars in value for their stakeholders.
Our quality-driven development process ensures that your product will meet all applicable standards and requirements. Effective planning and diligent program management guarantee that your device will perform well and be completed on time and on budget.
HDA provides contract manufacturing and compliant pilot production services to the medical industry, building both durable goods and disposables in our FDA registered facility. With on-site engineering support we routinely achieve on-time delivery with no surprises. Whether you need ten units or ten thousand, HDA will build your product for you.
We have the right blend of size, resources and experience to ensure that your product is well made and meets your specifications every time. With each product that we build, our decades of manufacturing experience, craftsman’s eye and dedication to quality continue to earn our customers’ trust.
HDA Technology is ISO13485, FDA and FDB registered.
HDA specializes in developing and manufacturing Medical Devices. Our experienced team has a track record of successfully accomplishing complex and high-technology projects where others fall short.
Let us help you to focus on your core business – we will take care of design, production and support.
Contact Us
HDA Technology is a full-service medical device contract manufacturer and developer based in Lake Forest, California. We handle engineering and prototyping, manufacturing, electronics and PCB assembly, testing and quality control, and compliant clinical pilot production for medical device companies nationwide.
HDA Technology has been developing and manufacturing medical devices since 1982, giving clients decades of hands-on experience with regulated device production.
Yes. HDA Technology is ISO 13485:2016 certified, FDA registered, and California FDB (Food and Drug Branch) registered, meeting the quality and regulatory standards required for medical device manufacturing.
HDA Technology's manufacturing facility is located at 4 Rancho Circle, Lake Forest, California. We design and manufacture for clients throughout the United States.
HDA Technology supports programs from low-volume clinical pilot production through full-scale contract manufacturing, so clients can stay with the same partner as their device moves from development to production.
You can reach out through the contact page with your project details — device type, expected volume, and timeline — and the HDA team will follow up to scope the engagement.
