Medical Device Manufacturing

What’s next for your revolutionary medical device concept?

Navigating the design, manufacturing, and regulatory processes of medical device development is difficult without sufficient experience and expertise. Here is where your search ends: HDA Technology is a full-service medical equipment contract manufacturing company with decades of experience developing and producing high-quality products for our clients.

HDA has experience partnering with start-ups, mid-size companies, and multinational corporations. We have a long-term track record of producing effective, reliable medical device products. We are one of Southern California’s leading medical equipment contract manufacturers because of our long-time commitment to excellence and quality. Collaborate with HDA to make your medical device concept the next successful product introduction.

HDA Optimizes Development With Pre-Compliance Evaluation And Testing

Regulatory certification is an intimidating step in development for many companies, but it’s just another step in the process for HDA. As experienced medical device manufacturers, we understand that the regulatory process could potentially delay or block a product’s path to market.

To mitigate lengthy and costly delays in production, HDA evaluates and tests the product throughout development to make sure it passes regulatory certification without any complications.

HDA is ISO 13485 certified and registered with the U.S. Food and Drug Administration (FDA) and California Food and Drug Branch (fdb) to manufacture safe, effective medical device products. We guarantee the safety and efficacy of our products. As full-service medical equipment contract manufacturers, we adhere to the development requirements of our governing regulatory bodies.

We utilize device design controls throughout development, maintain detailed documentation, and manage after-sale support and service to ensure the safe function of your products throughout their life cycles.

Efficient, Lean Manufacturing In Our Large And Reconfigurable Facility

HDA’s FDA-registered facility can manufacture high-volume orders with consistent quality and efficiency. Our lean manufacturing structure facilitates robust, cost-effective manufacturing to meet any production goal.

Because of our large, open facility and reconfigurable design, we can quickly and easily adapt our manufacturing equipment and processes to cater to your product’s needs. Combined with our lean manufacturing production process, we operate on reduced costs with improved production quality and lowered lead time.

Our facility and manufacturing process offers a variety of benefits for you: 

  • Improved Quality. Expert HDA engineering and quality assurance professionals actively work to identify quality issues in our products and development process. This process identifies the root cause of large-scale quality defects and eliminates them before they pose a threat.
  • Lower Costs. We remove inefficiencies from the production process to reduce costs and offer cost-effective manufacturing solutions directly to our customers. Raw materials are procured strategically to combat supply chain delays,  prevent overproduction and reduce costly storage costs.
  • Timely Production. Lead times are reduced through the elimination of inefficient practices. Less time is wasted in operation and unnecessary personnel hours, reducing the costs of production and manufacturing time.

Minimal Waste. HDA holistically manages the development process from start to finish to streamline output and time to market. Excess inventory, overproduction, and unnecessary procedures are eliminated to provide more value to the customer.

Time-Proven Quality Through Refined Development Processes

Throughout HDA’s years in medical equipment manufacturing, we have continuously refined and improved our development process to offer our clients an easy, smooth experience. Our consistent quality and successful results are owed to our expertise in the industry. If your goal is to get your product to market as efficiently and safely as possible, HDA is renowned for its quality and reliability under tight deadlines. We invite you to get in touch to learn more.

Fully Customizable Contracts: Medical Equipment Contract Manufacturing To Fit Your Unique Needs

We have experience producing world-class medical devices to fit the unique needs of our clients. Our scalable development process and manufacturing can shift to deliver your production goals. Whether you’re looking to develop a proof of concept prototype or kick off high-volume production, HDA has manufacturing solutions to help you reach your goals.

Demonstrate Your Design With A Proof Of Concept Prototype

Do you want to prove the critical function of your innovative new medical device design? 

Creating a prototype as a proof of concept can be key to engaging investors and brining your product to market. HDA is prepared to help your medical device program at any stage in the development cycle and produce a high-quality prototype to prove its function and design.

Complete List of Manufacturing and Production Services:

We offer

  • Purchasing and BOM Management
  • Compliant Clinical Unit Production
  • Prototype Production
  • Volume Production
  • Box Build
  • System Build
  • Disposables
  • Calibration
  • Final Test
  • After-Sale Support and Service

HDA is based in Orange County, California, and provides state-of-the-art technical expertise with old-world craftsmanship to medical startups and multinational companies worldwide. We are proud to partner with you to take your newest ground-breaking innovation from concept to market.

HDA Technology