Assembling a medical device requires precision, a controlled environment, and consistency you can validate every unit, every time. At Pro-Tech Design, that’s all we do. We provide expert assembly services in our state-of-the-art Class 10,000/ISO 7-rated cleanrooms, with all three of our locations ISO 13485 certified and FDA registered. Every project is guided by an experienced team who understands what it takes to get your device right.
Your device can be cleaned, assembled, packaged, and labeled under one roof, reducing the handoffs, transport, and coordination that come with using multiple vendors. Our cleanroom facilities support each of these steps in sequence, so your product moves through production with fewer transfer points and less risk of contamination or delay.
Building and maintaining an in-house cleanroom is a significant investment, often sitting idle outside of active production. Contract assembly lets you pay only for the production time you need, while a partner like Pro-Tech handles the cleanroom, equipment, and process - freeing your team to focus on designing the medical device itself.
Our cleanrooms are built to limit contamination and protect your device throughout assembly, with HEPA filtration, controlled gowning areas, and strict environmental protocols at every stage. Production lines are cleaned regularly, and every cleanroom is tested monthly and certified annually, so your product is assembled in an environment that consistently meets regulatory standards.
Setting up an entire production line for a single product is a major investment, especially for one that’s new or unproven. Our lines are already in place and equipped to handle it, from hand-assembly to fully automated production, low-volume runs to high. That flexibility means your device moves into production without the time or cost of building a dedicated line.
Every product is assigned a dedicated manufacturing engineer who oversees it from concept to finished device, backed by an assembly team experienced in intricate builds. That experience drives down cost without sacrificing quality. And because we work across a wide range of medical devices, we bring proven techniques from one line to the next.
Contract Assembly services to meet the needs of medical device customers large and small.
We adhere to the highest quality standards and are committed to maintaining that standard every day. You don’t have to worry about developing production processes on your own to meet that standard, we have already done it for you.
Find answers to frequently asked questions or contact us to start a conversation.
At Pro-Tech Design, quality is our top priority. We operate ISO 13485-certified facilities with clean room manufacturing spaces to maintain the highest industry standards. We also provide quality control throughout the device assembly process to ensure that your product meets all regulatory requirements.
Contract assembly allows you to focus on the medical device design while we manage the production. By working with Pro-Tech Design, you only pay for production time, eliminating the costs associated with maintaining idle equipment. Our assembly facilities, state-of-the-art equipment, and experienced production staff ensure that your product reaches the market quickly and efficiently.
Our assembly operations are designed to accommodate both small and high-volume production runs. With automated systems and hand-assembly capabilities, we provide flexibility to meet diverse client needs, from diagnostic devices to protective equipment. We also have three redundant manufacturing facilities that provide scalability and enhanced capacity.
We provide sterile or non-sterile medical device assembly for customers in cardiovascular, orthopedic, diabetes, wound care, and neurostimulation markets, among others.
