Custom Sewn and Sealed Product Manufacturer for the Medical Industry
TPI Custom Solutions is an FDA registered custom contract manufacturer specializing in sewn and welded solutions in the medical soft goods industry. Our soft medical goods are produced with custom-made commodities and distinctive R&D operations. In being ISO 13485:2016 certified and an FDA registered company, our sophisticated sewing and sealed welding solutions guarantee an elevated level of quality control to turn a customer’s concept into actuality. Our additional services in custom 3D printing and class 8 clean rooms can add a higher value to a customer’s distinctive specification. As a company with proven processes, TPI excels in the discovery and concept development of R&D that advances its design services to its final product.
ISO 13485:2016 Certification
ISO 13485:2016 is a quality management system specifying the standards for producing medical devices and related services. As a certified ISO 13485:2016 medical soft goods company, TPI Custom Solutions can fulfill its promise of continuous improvement towards quality that exceeds customer and regulatory requirements in the medical industry. We are glad to share that TPI Custom Solutions is also FDA-registered. Being an FDA-registered company proves that TPI Custom Solutions’ ability to produce medical goods will always meet and exceed federal regulation qualifications.
Medical Soft Goods
Founded in 1981, TPI Custom Solutions are experts in developing and producing custom medical soft goods. The engineering and R&D of developing custom-made solutions to create customer concepts have stayed true due to its quality control of excellence. With many years of experience, TPI Custom Solutions is a trusted company advancing soft medical goods through its determination of innovation and operation technology. From medical device bags, medical instrument bags, and custom tactical bags to patient transfer boards and inflatable medical bed covers, TPI Custom Solutions is dedicated and committed to transcend your expectations in any ideal product you could have. Our diverse experience allows us to create anything within the soft goods market of the medical industry.
Custom Sewing Services
To meet our customer needs and specifications, TPI Custom Solutions offers custom sewing services to create custom-made prototypes and more. With a wide range of sewing machines, TPI Custom Solutions can create many complex designs. Our engineering experts and sewing machines can virtually stitch all types of fabrics to build a framework for any product. In addition, TPI Custom Solutions also provides CNC contract cutting that can construct intricate and precise cuts for any soft medical goods. With our integrated technology, the trailblazing ultramodern CNC cutting software enables our engineering team to cut every material or fabric that requires digitizing precision.
Medical Soft Good Welding
At TPI Custom Solutions, we offer a wide range of welding services. Our fabric welding allows us to create the special bonding of the material in producing the most secure and unpassable closure to accommodate and repel any air or substances. TPI’s ultrasonic welding allows us to join materials for specific projects. The ultrasonic acoustic vibrations and pressure allow a more substantial bond when joining materials. Another excellent welding service that we offer is our radio frequency welding. With RF Welding in medical soft goods production, TPI Custom Solutions has proficiency in making robust seals that comprise air, gels, and liquids. Our custom tooling in welding can develop any product for your project.
As an innovative and technological medical soft goods manufacturing company, we are proud of our exceptional product development and sewing operations. To create your exclusive product, our extensive R&D, materials, and assembly knowledge enable us to produce the most challenging proposals. As an option, TPI Custom Solutions provides custom 3D printing that refines the production process. Our dual extruder 3D printer gives users the most control to generate a superior solution. As a dual extruder 3D printer, TPI Custom Solutions can also provide a sizeable build capacity for designs that target more significant parts and pieces. TPI’s 3D printer services can also reduce project time and save expenses from injection molding. Our desire to collaborate with our customers is to produce the most premier outcome.
Class 8 Cleanrooms
Indeed, some products may need to be produced in a controlled environment. TPI Custom Solutions is delighted to provide class 8 cleanrooms. Our class 8 cleanroom certification achieves the requirements of a maximum particle count of 100,000. The cleanroom manufacturers work with present-day machinery to construct any sensitive products. In a clean and particle-free space, environmental control allows us to provide our customers with the highest quality to produce their custom elements, results, and packaging.
Global Material Sourcing
With over 60 years of collective experience, TPI can produce your specific needs with our stock materials. These stock materials include nylons, polyester, laminated foam products, and others. If no stock materials fit your needs, TPI Custom Solutions can also source custom made materials created and produced specifically for your specifications. Such custom materials can include laminated materials to meet particular density or performance, anti-static, and anti-microbial coatings, as well as dyed fabrics matching custom PMS colors. The production and prototype team will collaborate with you to construct methods and determine the equipment to produce the most pleasing and long-lasting result.