HDA Technology

HDA Technology is a full-service Product Development and Manufacturing Firm specializing in innovative lifesaving and life-enhancing Medical and Aerospace products. We offer complete design services for Class-I, II and III Medical Devices from concept through final product, and manufacturing from compliant pilot builds through volume production. Our quality system is ISO13485, AS9100, and ISO9001 registered for design and manufacturing, and we are an FDA and FDB registered medical manufacturing facility.

Products and Services

HDA provides contract manufacturing and compliant pilot production to the medical device and IVD industries. Our customers include medical startups, mid-size companies and multinational corporations, with production volume ranging from 5-50 compliant pilot units for clinical testing, to hundreds or thousands of units per month for commercial production. We build both durable goods and disposables in our FDA registered facility in Orange County, California.

Our product development process is quality-driven to guarantee that your device or LRU will meet all applicable standards and requirements. Diligent planning and program management make sure that your product will perform properly and come in on time and on budget. Design for Compliance and in-house pre-compliance testing is built into our development process, ensuring your product will pass certification testing as quickly as possible.

Manufacturing Processes

Our focus is on high complexity low and medium volume, and mission-critical medical and aerospace products, designed and manufactured under our registered quality system and in our FDA registered facility.