At HDA, we have been providing contract medical device manufacturing services to the greater Southern California region for over 15 years — including here in Irvine. Our experienced team of engineers and technicians is dedicated to producing high-quality medical devices that meet stringent safety requirements, FDA guidelines, and industry standards. We utilize a wide range of advanced technologies and processes to deliver superior results for our clients.

We specialize in custom contract medical device manufacturing projects ranging from simple prototypes to complex products with multiple components. Our process includes prototyping and design assistance, component sourcing, assembly, packaging, and testing—all under one roof. We work closely with our clients every step of the way to ensure their product is produced according to their exact specifications on time and within budget.

Why Work With A Contract Medical Device Manufacturing Firm?

Working with a contract medical device manufacturing firm can offer many advantages for companies looking to outsource their production. Our team is well-versed in the complexities of medical device production, regulatory requirements, and compliance. We have extensive experience working with multiple medical device components and materials, allowing us to minimize costs while still delivering high-quality results.

Our Irvine-adjacent contract medical device manufacturing facility is also equipped with the latest automation technology, which helps to streamline our processes and speeds up lead times — ultimately resulting in fewer costly delays. Furthermore, our experienced engineers and technicians are committed to providing excellent customer service by ensuring open communication throughout the project lifecycle and responding promptly to any inquiries or requests that you may have.

When it comes to contract medical device manufacturing and help with creating your medical device prototype, HDA is the clear choice for companies in Irvine and throughout Southern California.

Medical Product Development For You

HDA works with both medical startups and leading medical device manufacturers. No job is too big or too small.

Medical product development starts with a plan. We take your ideas and bring them to life. Our team of experienced engineers and technicians can help you design, prototype, test, manufacture and package a medical device that meets industry standards as well as FDA guidelines.

Our contract medical device manufacturing service includes:

• Design assistance and prototyping
• Component sourcing
• Assembly
• Packaging
• Testing

We strive to make the contract medical device manufacturing process easy for you. Our team is available to answer any questions you have throughout the entire process. Contact us today if you’re looking for contract medical device manufacturing in Irvine or anywhere else in Southern California! 

Properly Certified For Contract Medical Device Manufacturing

For your manufacturing needs, HDA Technology is ISO13485, FDA and FDB registered. This means that we comply with the highest standards of contract medical device manufacturing so that you can be sure your product is safe and reliable.

Our contract medical device manufacturing experts adhere to Good Manufacturing Practices (GMPs) and work hard to ensure each product meets FDA, CE & UL certifications. We go above and beyond in our commitment to quality assurance and ensuring customer satisfaction with every medical product we manufacture.

With our contract medical device manufacturing services, you can trust that your product will meet all industry requirements. ISO13485 certification means that we have implemented a quality management system that meets all of the requirements for medical device manufacturing. Our certification also ensures that our contract medical device manufacturing services are regularly audited for compliance and safety.

Our contract medical device manufacturing services guarantee you the highest level of quality assurance so that your product is safe and reliable.

Compliance Testing Support

In contract medical device manufacturing, compliance testing is essential. HDA Technology offers electrical and mechanical testing services to ensure your product meets all applicable industry standards.

Our contract medical device manufacturing experts are up-to-date on the latest regulatory requirements and can provide guidance on best practices that should be followed when developing medical devices. In addition, our team has extensive experience in debugging and troubleshooting any issues or defects discovered during the development process.

Ultimately, contract medical device manufacturing is an integral part of bringing a product to market safely and efficiently — and HDA Technology is here to help support you every step of the way. Contact us today for contract medical device manufacturing in Irvine and Southern California!  We look forward to hearing from you.