HDA Technology Logo - medical devices

HDA Technology

medical devices
China's Best One-Stop Medical Equipment Provider
About

HDA Technology designs and manufactures innovative medical products for our clients. We offer complete Design Services for Class-I, II and III Medical Devices, and Contract Manufacturing for Compliant Pilot Builds through Volume Production. Founded in 1982, HDA is ISO13485, FDA, FDB, AS9100 and ISO9001 registered. From our FDA registered facility in Orange County, California, HDA provides Contract Manufacturing and Compliant Pilot Production to the Medical Device and IVD industries. Our customers include startups, mid-size companies and multinational corporations. Volume ranges from small runs for clinical testing, to hundreds or thousands of units for commercial production. Our quality-driven design process guarantees your product will meet applicable standards and requirements. Diligent planning and program management ensure your device will perform properly and come in on time and on budget. Design for Compliance and in-house pre-compliance testing are built into our process, so your product will pass certification testing as quickly as possible.

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Keywords
medical product developmentmedical contract manufacturingfda registered manufacturercompliant pilot buildscompliant clinical productiontransfer to productioniso13485 registeredas9100 registerediso9110 registeredmedical device designmedical device manufacturingmedical equipment manufacturingmedical technologyhealthcareiso 13485 certificationcleanroom productionmedical device developmentfda registeredregulatory planningmedical equipment and supplies manufacturingproduct developmentcost-effective manufacturingmanufacturing scalabilitymechanical engineeringcontract manufacturingproduct validationclinical productiontraceabilitymedical device contract manufacturingsoftware development
Company Information
  • Employees12
  • Founded1983
Location

4 Rancho Cir, Lake Forest, California, United States, 92630

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