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.
The well-rounded team at HDA features expert engineers, seasoned regulatory specialists, and development professionals with years of knowledge under their belts. Our job is to get products like yours to market as a full-service medical equipment contract manufacturing company. HDA’s refined development process is ready to take over your device’s production at any stage in its journey and see it through its complete product life cycle.
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 on the market.
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.
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 accurately to prevent overproduction and costly storage costs.
- Fast Production. Lead times to begin manufacturing 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.
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
Do you want to prove the critical function of your innovative new medical device design? Creating a prototype as a proof of concept is essential to getting 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.
OUR PRODUCTION PROCESS HANDLES HIGH-VOLUME MANUFACTURING
We believe that consistency, cost-effective production, and high quality are essential in high-volume manufacturing. HDA has experience scaling production to meet high-volume customer goals while delivering quality and consistency.
Our skilled engineers and production management team develop expertly crafted products designed to meet high demand levels. Leverage our robust medical device contract manufacturing services to affordably and safely get your new product into the marketplace.
READY YOUR DEVICE WITH FULLY COMPLIANT PILOT PRODUCTION
Support your 510(k) filing and clinical testing with HDA’s Compliant Clinical Prototype Production service. Our production facility can produce low-volume, fully compliant orders to help you meet FDA testing and filing requirements. Each medical device is manufactured in our ISO 13485-compliant facility. Take advantage of our world-class manufacturing capabilities and get your medical device into development today.
HDA is committed to providing cost-effective, reliable medical equipment contract manufacturing services that turn your innovations into successful realities. Partner with one of Southern California’s most well-established product development companies for your next medical device. Contact us today and tell us all about your idea!