A Seamless Journey From Concept To Market
HDA provides medical device development, manufacturing, and compliant pilot production for the medical device industry. Our customers include medical startups, mid-size companies, and multinational corporations.
Our refined medical device development and manufacturing processes will take your product from concept to delivery.
We build durable medical equipment and disposables including handheld, tabletop, diagnostic, and therapeutic devices.
Our specialization is in Class I and Class II devices, including but not limited to:
We offer:
We are one of very few firms offering low-volume compliant device manufacturing and compliant prototyping from our FDA-registered facility in Orange County, California.
HDA Technology offers comprehensive medical device development services, guiding clients from initial concept through to production. With decades of experience, our team ensures products meet regulatory standards and market demands efficiently. Services include prototyping, pre-compliance testing, and full-service engineering, all designed to bring innovative medical devices to market swiftly and effectively.
HDA Technology provides end-to-end medical device manufacturing services, managing everything from material sourcing and process development to testing and compliance. Utilizing lean manufacturing, we ensure cost-effective, high-quality production with scalable solutions for both low- and high-volume orders. Our reconfigurable facility (including an ISO 8 cleanroom and large open manufacturing floor) and experienced team minimize lead times, streamline processes, and maintain strict quality control. Specializing in compliant pilot production, prototype development, and full-scale manufacturing, HDA supports clients through every stage, from concept to market, with end-to-end compliant and high quality medical device manufacturing.
HDA Technology offers in Compliant Clinical Prototype Production, delivering low-volume, fully compliant medical devices for clinical trials and regulatory submissions, including 510(k) filings. Our FDA-registered, ISO 13485-certified facility ensures precision manufacturing with full traceability, documentation, and rigorous quality control. We develop and validate custom assembly and test procedures, ensuring prototypes meet clinical and regulatory standards. With expertise in risk management, verification, and audit readiness, we provide startups and established companies with high-quality, regulation-compliant devices ready for clinical evaluation and market approval.
With many decades of experience, HDA’s team has worked with everything from small startups to large multi-national corporations. Browse through our past projects to learn more about how we can help you launch your next medical device idea.
Providing state of the art technical expertise with old-world craftsmanship to medical startup and multinational companies worldwide, HDA is based in Orange County, California. We are proud to partner with you to take your newest ground-breaking innovation from concept to market.
