Choosing to outsource your medical device production means trusting a partner with the safety of your product and the reputation of your company. At Pro-Tech Design, we’ve earned that trust for over 45 years. In fact, our very first customer is still a customer today! We offer full outsourcing solutions, from packaging and assembly to on-site lab testing, across our ISO 13485 certified, FDA registered facilities. We also manage sterilization through our trusted network of certified partners, so your device is covered end to end.
Producing a medical device requires more than good engineering. It takes a validated production environment, regulatory expertise, and capital most companies would rather invest elsewhere. Outsourcing with a qualified contract manufacturing organization lets you tap into that infrastructure and experience without the upfront cost, so your team can stay focused on designing a better device while an experienced partner handles the rest.
Outsourcing works best when you’re not stitching together multiple vendors. We handle it all under one roof, from component procurement and cleanroom assembly to packaging, labeling, and warehousing. Sterilization is managed through our trusted partner network. One point of contact, one quality system, and one team accountable for your device from start to finish.
For us, quality isn’t a requirement. It’s a responsibility we take personally. Behind every device we touch is a patient who’s trusting it to work. That mindset shapes how we operate every day, from the first conversation to final delivery.
Our certifications aren’t just requirements to meet. They’re proof of a standard we hold ourselves to every day, and it’s a standard our customers notice. Our average customer relationship spans more than a decade, and that kind of trust is something we work to earn with every partnership.
Find answers to frequently asked questions or contact us to start a conversation.
No, we do not do any molding, machining or manufacturing of the components themselves. Instead, we focus on cleaning and assembling medical device components into finished products.
Once the devices are assembled, then we package them into primary and secondary packaging, print and apply labels, and manage sterilization. We can perform all of these services or whatever individual steps our customers require.
This is very typical for a contract manufacturing company.
Yes, we can handle the full procurement process and management of all components for our customers through their defined vendors or through vendors we already work with.
This includes setting up supply agreements where we keep an inventory stock of components for future builds for our customers.
Over the years, we have heard from customers that this is dramatically easier for them to coordinate component procurement with one partner rather than manage separate, individual vendors.
We offer a full range of contract packaging services, including:
Our ultimate service is to provide protective packaging so that your medical device is safely delivered to the end user.
There are many key considerations when selecting an outsourcing partner. Here are some of the most important factors to consider:
1. Cost: Obviously, cost is a major consideration when selecting an outsourcing partner. You’ll want to get quotes from a few different companies and compare pricing.
2. Services Offered: Make sure that the company you’re considering outsourcing to offers the services you need.
3. Commitment to Service: Make sure that the partner you choose has a strong commitment to servicing its customers and has a history of developing long-term relationships.
Complete the contact us page and we will contact you to discuss the details of your project.
Our engineers will review the device and its components, confirm your requirements, and identify any production needs to outline an assembly protocol. A detailed quotation will follow that includes production costs and any validation recommendations.
