In addition to our medical device assembly and packaging capabilities, Pro-Tech Design is also an ISO 13485 certified medical sewing contractor. We specialize in all types of wearable medical devices and carrying cases.
We provide custom sewn solutions for medical device companies and their patients. We handle product development from design through sample production and full-scale manufacturing.
Patient comfort matters for wearable medical devices. Our team develops custom sewn products to fit your device and the people who use it.
Designed around real bodies and routines
Design, samples and full production
Built where your budget needs it
From medical device wear and carry accessories to sales presentation kits, we design and produce a broad range of sewn products that are stylish, functional and durable. We employ a wide variety of materials and sewing techniques depending on the project.
We offer complete design solutions using the latest design software, 3D printing, and rapid sample prototyping. With decades of experience developing sewn medical products, we understand how to design wearable solutions and cases that compliment your device.
We can handle small runs or large scale jobs. Our sewing capabilities include:
We provide custom solutions tailored for different sectors of the medical device market. Most of our customers require complex sewn assemblies to support custom wearable medical devices and cases that safely and securely hold monitoring devices, continuous medicine delivery pumps (insulin pumps) and neuromodulation treatments.
We are one of the few contract sewn manufacturers in the industry who are also ISO 13485 certified to meet the demanding standards of the medical device industry.
Some of the medical markets we serve include:
Our domestic sewing facility in Santa Fe Springs, CA is ISO 13485 certified and FDA registered.
Certified quality system in an FDA-registered facility.
Flexibility on cost and timing without changing standards.
Total project management software on every program.
Track your project anytime for full transparency.
Our skilled engineers and sample makers work hand-in-hand with you to create products that satisfy your specific requirements. We use your device, solid models, drawings and sketches to generate fast turnaround concept samples to meet your timing requirements. We work with you through every step of the process to ensure your patients receive a final product that works with their lifestyle.
Soft-sided and pressure-formed cases, device wear items, event monitoring, belt clips, harnesses and sales presentation kits.
A pharmaceutical company's combination drug/pump therapy required patients to wear a large infusion pump at all times, limiting mobility and tolerance. As part of the therapy, the wearable needed an FDA-registered, ISO 13485-certified maker and UDI-compliant labeling.
Our design team developed vest, waist and shoulder options that let patients program therapy without removing the device. We built prototypes for human factors trials and durability testing, ran risk analysis, then ramped to full production.
Launched in the USA and worldwide.
After two years on the market, we are working with our customer to improve the product using patient feedback.
Find answers to frequently asked questions about Pro-Tech’s sewn medical product capabilities.
Pro-Tech specializes in a wide variety of sewn medical products, including carrying cases, accessories, wearables, and sales presentation kits. We offer the flexibility of manual or automated custom sewing operations at US or OUS medical device manufacturing facilities. We provide custom designs based on years of experience creating the perfect sewn solution for any customer need.
Our team brings decades of experience to sewn medical product manufacturing. We are ISO 13485 certified.
We work with a wide array of materials including Nylon, Lycra, Polyester, Neoprene, Leather, and Vinyl. We tailor the material choice and each product solution to meet the unique needs of our customers and we have the flexibility and experience to design wearable products that meet their budget and timing requirements.
We are an ISO 13485-certified contract manufacturer – one of the few with that certification in the sewn medical industry. That means that we must adhere to strict quality standards and sewing processes and the customer can be assured that we will deliver a quality product. In addition, we have years of experience designing custom solutions to the highest quality standards and have a reputation in the medical industry for creating unparalleled custom-sewn solutions.
Pro-Tech serves a variety of industries within the medical field, offering sewn solutions for medical device companies in Patient Monitoring, Diabetes Care, Chronic Pain Management, Parkinson’s, and Incontinence among others.
Yes, Pro-Tech routinely develops custom-sewn solutions for customers. Our experienced team of engineers and designers works closely with medical device companies to design and produce dependable products, ranging from custom-fitted wearable devices to sales presentation kits.
Pro-Tech has the capability to produce its sewn medical products in the U.S. at our own facility or overseas, where we have long-standing partnerships with our suppliers. So, depending on the customer’s requirements, budget, and timeline, we have the flexibility to produce their item either in the U.S. or OUS.
In addition to our extensive history in medical sewing services, Pro-Tech also provides contract packaging, cleanroom assembly, sterilization services, and validation testing for medical devices. We offer a comprehensive suite of solutions to protect our customer’s medical device products. If you want to learn more, feel free to reach out to us at our contact phone or via email address.
