HDA Technology, Inc.

HDA Technology, Inc. is a medical device contract manufacturer and product development firm specializing in engineering, prototyping, and compliant clinical production. Founded in 1982, the company serves medical startups and established medical device manufacturers by bridging the gap between product concept and full-scale commercialization. Core services include medical device development (engineering, prototyping, regulatory planning), compliant clinical pilot production, and FDA-registered contract manufacturing of both durable goods and disposables. The company operates an FDA-registered manufacturing facility in Lake Forest, CA, with on-site engineering support and quality assurance capabilities. HDA holds ISO 13485 certification, FDA registration, and California FDB registration. The firm has demonstrated expertise in complex, high-technology projects including reverse engineering of undocumented circuit boards, specimen sorting automation, and custom medical device assembly. Manufacturing capability ranges from pilot runs (10 units) to scalable production (10,000+ units). Customers include major diagnostic companies (Quest Diagnostics), aviation suppliers (Airbus), and medical device manufacturers across in vitro diagnostics and clinical applications. The company emphasizes quality-driven processes, on-time delivery, and on-budget performance with dedicated program management.