HDA Technology

About

HDA Technology is a full-service contract development and manufacturing firm specializing in therapeutic and diagnostic medical devices. We offer complete design services for Class-I and II medical devices from concept through final product, and manufacturing from pilot builds through volume production.

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

We offer manufacturing and compliant pilot production services tailored for the medical device industry. Our clientele includes medical startups, growth-stage companies, and multinational corporations. We support production volumes ranging from 5 to 500 compliant pilot units for clinical testing to hundreds or thousands of units per month for commercial production. Our facility in Orange County, California, is equipped to manufacture durable devices and technical disposables, ensuring quality and compliance at every stage of the process.

HDA Technology is ISO 13485 registered for medical design and manufacturing. Our FDA-registered facility, is also licensed by the California FDB for medical device manufacturing, ensuring the highest standards of quality and compliance in our operations.

  • Audio
  • BMS (Battery Management System)
  • DSP
  • FPGA
  • General Digital-Analog
  • High Density-BGA
  • Power Supply
  • SBC
  • USB
  • Certification Example: FCC/RED
  • Design for Manufacturing
  • High-Volume Production
  • Low to Medium Volume Production
  • Prototype Assembly
  • Prototype Testing
  • Test Fixture Development
  • Turnkey Volume Production
  • Enclosure Design
  • Full Product 3D Modeling
  • PCB and Component 3D Modeling
  • Bootloader
  • C/C++
  • GUI
  • Java
  • Linux
  • Python
  • RTOS
  • Security
  • Analog Simulation
  • Block Level System Design and Integration
  • Design for EMI RFI Immunity
  • Design for Testability
  • PCB Design/Layout
  • Schematic Capture
  • UX/UI
  • Bluetooth
  • RF Design
  • Medical
  • Altera
  • AMD/Xilinx
  • Analog Devices
  • Infineon
  • Intel
  • Lattice
  • Microchip
  • Nordic
  • NXP
  • Renesas
  • STMicro
  • Texas Instruments

Contact

4 Rancho Circle, Lake Forest, California 92630 USA
Hunt Dabney
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