Medical DeviceQualified Supplier Directory
Qualifications: ISO 13485, FDA Registered, CGMP Certified, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Overview An end-to-end solutions provider, Tegra Medical offers contract manufacturing, from prototyping to production of...
An end-to-end solutions provider, Tegra Medical offers contract manufacturing, from prototyping to production of complex components and finished devices, as well as full finishing, assembly and packaging. We make products for leading surgical, interventional and orthopaedic companies in the areas of orthopaedics, cardiac care, women’s health, neurology, ophthalmology, radiology, pain management, diabetes and other medical specialties. The types of procedures often include arthroscopy, endoscopy, joint reconstruction, biopsies, and drug delivery using a wide range of devices such as implants, needles, cannula, fixation systems, probes, wires, catheters, stylets, mandrels and many more.We have 220,000 sq. ft. of ISO13485-registered, FDA QSR- compliant manufacturing space, including over 25,000 sq. ft. for prototyping. With an exclusive focus on medical device manufacturing, we answer our customers’ needs for innovative solutions, rapid turnaround and dedicated customer service.
Medical Device Manufacturing Capabilities
Tegra Medical’s capabilities for medical device manufacturing range from grinding and machining to the creation of complete, finished medical devices:
- Laser cutting welding, marking - With 24 lasers and 24/6 operations, we have the capacity to support prototyping needs as well as high volume production of a wide range of material including Nitinol, Platinum, Nickel, Titanium, Inconel, Hastelloy, 300 and 400 series Stainless Steels and many more.
- Precision grinding - customers have long relied on our grinding shops (formerly New England Precision Grinding and American Medical Instruments) for the highest quality grinding services. We handle the most demanding geometries with tight tolerances. Our expertise includes needle pointing, thru-feed grinding, in-feed grinding and electrochemical grinding.
- CNC Swiss machining - we offer the best in CNC Swiss machining performance, supported by the latest equipment and manned by expert technicians. Our 23 CNC Swiss machines offer precise, repeatable machine movements that can be programmed for optimal speeds, feeds, and machine cycles.
- CNC milling and turning - Swiss-style machining centers, multi-access mills and lathes, and experienced toolmakers offer exceptional precision machining for tight tolerance work on metal components used in interventional, orthopaedic and minimally invasive devices.
- Nitinol memory shape setting - Tegra Medical has been precision machining, laser cutting and laser welding Nitinol for many years. We have long-standing working relationships with the raw material suppliers and work with the Nitinol wire, ribbon, and tubing you need for your medical device manufacturing.
- Electronic discharge machining - we offer extensive EDM capabilities, which provide a superior manufacturing process for creating complex geometries. EDM is well-established as an essential capability for manufacturing medical devices, especially when working with tight tolerances and in circumstances where you need high accuracy and reproducibility.
- Gundrilling - gundrilling is an ideal solution for most deep hole requirements. The process produces accurate, repeatable holes with excellent surface finishes. It is commonly used to produce cannulated screws, nails and drills. The versatility of gundrilling machinery makes the process ideally suited for low as well as high volume production.
- Electrochemical machining and deburring - we offer conventional electropolishing (EP) and the CoolPulse™ electrolytic process. These processes can produce burr-free edges on complex geometries; create highly polished, smooth finishes and radiused edges; and deburr, polish, and radius complex components cost-effectively.
- Stamping - progressive die stamping can encompass punching, coining, bending and several other ways to modify raw material, combined with an automatic feeding system. Precision metal stamping is a very cost-effective process for high volume, single use metal components used in minimally invasive surgery.
- Custom and specialty needles - Tegra Medical is your trusted partner in American-made medical needles. We offer nearly any type of needle point and procedure needles for all markets. We can also custom-manufacture needles for your unique needs.
- Wire and tube forming - wire and tube forming is an integral part of the medical device manufacturing industry. With the need for smaller and less invasive devices, customers have relied on Tegra Medical for years for custom wire and tube forming: bending, swaging, flaring, coining, and Nitinol heat setting.
- Insert molding - insert and injection molding is especially suited to medical device manufacturing because it ensures more uniform product quality and improved reliability. We offer PEEK molding for the cleanest edges, and can do both cold (water) and hot (oil) runner molding. We have a class 100,000 molding clean-room and a class 10,000 clean-room for assembly and packaging.
- Cleaning and finishing - we offer a variety of validated finishing and cleaning options, including ultrasonic cleaning, electrochemical deburring/polishing, electropolishing and citric passivation. Our specialists will work closely with you to determine the best finishing process for your medical device.
- Assembly and packaging - we offer a variety of assembly options in Class 7 or Class 8 environments, as well as bulk and individual unit non-sterile packaging or sterilization-ready packaging.
Our Genesis Tech Center (GTC) (TM) focuses exclusively on your medical device product development needs. We offer all our production-quality medical machining services to address the wide range of options needed to develop and launch new medical device products quickly and cost-effectively. Our tech center comprises experienced manufacturing engineers, project leaders, technicians and machinists, as well as dedicated equipment geared to solving the most pressing product development challenges with cost-effective solutions.
Overnight Shipment of Wire and Tubing
For customers that need wire and tubing shipped overnight, Tegra Medical keeps over a million feet of wire and tubing in inventory, including a wide selection of hypo tubing and stainless and Nitinol wire. In addition to our extensive in-stock PTFE and Parylene coated 304SS wires, we will custom-coat wires according to your specifications. We also produce simple mandrels in days. Easy, online ordering.
Quality & Regulatory
We are ISO 13485:2003 certified. Learn more about our quality practices.
For more information contact Tegra Medical
Dartmouth, MA United States
8 Ledgewood Blvd.
Hernando, MS United States
3414 Hwy 51 South Hernando, MS 38632
San Jose, Costa Rica
602 Global Park