ISO 13485 Manufacturers

Based in Carol Stream, IL, Aberdeen Technologies specializes in medical injection molding for plastic medical devices and components. They provide device prototyping, mold designs, manufacturing, and production runs for parts requiring strict tolerances. The company focuses on cost-efficient production of medical parts and is ISO 9001:2015 certified.

Based in San Marcos, CA, ACI Medical, LLC specializes in custom molding, injection molding, assembly capabilities, and part printing. The company manufactures its own medical devices, like ArtAssist® and VenaPulse®, demonstrating robust expertise in medical device production, making them a suitable supplier for ISO 13485 manufacturing needs.

Advanced Plastiform, Inc. specializes in medical injection molding and thermoforming for vital healthcare components. The company provides custom plastic manufacturing services, including vacuum forming, pressure forming, twin-sheet forming, CNC & robotic trimming, and value-added assembly, focusing on precision, quality, and safety.

Based in Houston, TX, AJ Medical Manufacturing is an ISO 13485 and FDA registered contract manufacturer of medical devices and components. They offer an agile, vertically integrated approach to medical device design and manufacturing. The company focuses on shortening time to market and delivering quality, Made in USA products for its client partners.

Applied Medical develops breakthrough medical devices for Minimally Invasive, General, Bariatric, and Cardiac Surgery. As a vertically integrated medical device company, it focuses on improving the accessibility and affordability of high-quality healthcare globally through its manufacturing and technological advancements.

Aprios, formerly Diversified Plastics, offers custom manufacturing services including precision injection molding and additive manufacturing. Specializing in medical devices, they provide ISO 13485 compliant quality management, an ISO Class 8 clean room, and comprehensive supply chain solutions from design to completion.

ARCH Medical Solutions Corp. provides precision machining, contract manufacturing, and supply chain integration for medical OEMs. Operating FDA-registered facilities nationwide, the company specializes in producing surgical implants, instruments, and medical devices. Expertise includes orthopedic, spine, dental, and surgical robotics production, as well as additive medical manufacturing.

Based in New Hope, MN, Ardel Engineering is an ISO 13485:2016 certified manufacturer specializing in precision medical machining. They work with new and unique materials, producing complex components to exact tolerances. The company delivers high-quality parts, meeting stringent demands for the medical device industry.

Based in Plano, TX, Argon Medical is an ISO 13485:2016 certified medical device manufacturer. They offer design, manufacturing, servicing, and contract manufacturing for sterile and non-sterile disposable medical products, providing compliant solutions for the healthcare industry.

Based in Santa Barbara, CA, Bentec Medical is an industry leader in medical silicone fabrication. The company provides custom silicone fabrication and OEM contract manufacturing for medical devices, leveraging extensive material science expertise. Services include design consultation, prototyping, regulatory support with FDA/CE, assembly, sterilization, and packaging for diverse medical fields.

Biotex Inc. is an FDA-registered and ISO 13485:2016 certified medical device manufacturer based in Houston, TX. The company offers contract manufacturing services, leveraging over 25 years of expertise in medical device development and commercialization. Biotex provides design, engineering, and manufacturing support for patient care solutions.

Contract Medical Manufacturing specializes in medical device manufacturing, offering comprehensive services from electrical-mechanical assembly, clean room operations, and sterile barrier packaging. They provide precision machining capabilities, including CNC, lathe, mill, and wire EDM, supporting various medical industry needs with a quality-driven approach.

Based in Elk River, MN, Cretex Medical offers contract manufacturing and engineering services for the medical device industry. They provide end-to-end solutions, including assembly, packaging, kitting, and sterilization. The company is ISO 13485 certified and FDA registered, ensuring robust quality systems.

The Cubbison Company is an ISO 13485 certified manufacturer, specializing in medical device manufacturing. This certification underscores their robust quality management system and commitment to producing high-quality medical devices according to stringent regulatory requirements.

D&R Products is an ISO 13485:2016 certified and FDA registered contract manufacturer specializing in medical devices. They provide comprehensive in-house manufacturing from bar stock to finished device, utilizing CNC machining, clean rooms, and welding. Expertise includes Nitinol and exotic materials.

Genesis Medical Plastics is a vertically integrated medical device manufacturer. They specialize in converting implantable PEEK and medical polymers into stock shapes, film, prototypes, and injection molded or machined components. The company provides ISO 13485:2016 certified and FDA registered manufacturing services for medical devices, from prototype to production.

Based in Addison, IL, GCM Precision Manufacturing offers comprehensive component manufacturing services. The company provides a wide range of product design and manufacturing solutions for OEM partners. They specialize in delivering integrated manufacturing support, extending beyond standard component production for diverse industrial needs.

Based in Hayward, CA, Halco is an ISO 13485 certified manufacturer specializing in medical device components. The company also produces custom hook and loop cable ties for structured cabling in AI data centers and fire-retardant hook and loop solutions for demanding industrial applications.

Based in Valencia, CA, H&H Machining provides ISO 13485 certified CNC machining services for medical devices, instruments, and implants, ensuring full lot traceability. They also offer AS9100D certified machining for aerospace and defense applications. Capabilities include rapid prototyping and both short and high-volume production runs for various industries.

Based in Indianapolis, IN, IMH Products is a contract manufacturer providing Made in America metal components and subassemblies. They specialize in metal fabrication, CNC machining, stamping, and weldments. The company offers services like laser cutting, forming, and finishing, explicitly providing components for medical devices for OEMs and engineering firms.

Integer provides market-ready products and comprehensive development services to medical device OEMs. Specializing in medical device development and battery solutions, they guide products from initial design to completed systems, catering to the specific needs of the healthcare industry.

Based in Renton, WA, KS Plastic LLC specializes in custom plastic injection molding and manufacturing services. They are ISO 13485:2016 compliant, providing medical device manufacturers with design, tooling, molding, and assembly. KS Plastic also serves automotive, consumer goods, and industrial sectors.

Lighteum Medical, based in San Diego, CA, manufactures precision nitinol, platinum, and coated metal components for medical devices, specializing in minimally-invasive surgery. The company provides rapid prototyping and extensive manufacturing capabilities, supplying OEMs worldwide. Their offerings include engineered components, marker bands, and advanced surface solutions.

Based in Carlsbad, CA, Lumos Diagnostics develops, manufactures, and distributes world-leading diagnostic technologies. The company operates an ISO 13485 certified OEM facility, providing custom development, manufacturing, and support services for diagnostic products. They deliver actionable information at the point-of-care.

Madison Ortho manufactures and supplies a diverse portfolio of orthopedic implants, instruments, and prostheses. From its Hollywood, FL facility, the company creates precise and safe medical devices. They focus on continuous product development to meet evolving orthopedic technologies and patient needs globally.

Based in Chanhassen, MN, Marshall Manufacturing Company is an ISO 13485 certified medical device contract manufacturer. They specialize in precision machining services, including Swiss machining, CNC milling, and turning. The company provides high-quality, cost-effective solutions for the medical industry, adhering to stringent manufacturing standards.

Based in Eau Claire, WI, MC&RS specializes in custom CNC machining and manufacturing for medical device components. The company provides precision-built parts, ensuring quality through critical processes and holding ISO 13485 certification. They serve the medical and aerospace industries.

Based in North Barrington, IL, Medical Murray specializes in the development and manufacturing of Class III medical devices. The company provides expertise in producing complex devices, including catheters for advanced modalities like IVUS and OCT, with operations in Illinois and North Carolina.

Based in South Jordan, UT, Merit Medical Systems, Inc. manufactures and markets proprietary disposable medical devices. These ISO-certified products are used in interventional, diagnostic, and therapeutic procedures across cardiology, radiology, oncology, critical care, and endoscopy, serving hospitals and physicians worldwide.

MICRO is an FDA and ISO 13485 certified contract manufacturer specializing in finished medical devices and complex handheld assembly. This company provides full-service product development and manufacturing solutions, from concept to completion, with US-based operations and an ISO Class 8 clean room.

Millstone Medical Outsourcing provides outsourced packaging, assembly, and testing services for medical device manufacturers. Capabilities include quality inspection, validation engineering, and finished goods distribution. Operating an ISO 17025 certified lab, they offer comprehensive testing for bioburden, sterility, and sterilization validation, supporting high-quality medical devices.

Based in Charlotte, NC, MW Components specializes in metal component manufacturing for orthopedic, medical, and surgical needs. They produce medical device components, precision wire forms, stampings, springs, fasteners, bellows, and shims. With over 20 US-based facilities, MW Components provides both stock and custom manufacturing solutions.

Based in Dayton, OH, Norwood Medical manufactures medtech innovations with precision and purpose. With nearly a century of experience, they serve demanding markets including cardiovascular, minimally invasive surgery, orthopedics, and robotic-assisted surgery. The company delivers high-quality manufacturing from its modern 700,000 square-foot facility.

OriGen Biomedical, headquartered in Austin, TX, is a medical device manufacturer founded in 1997. The company specializes in innovative cryopreservation and cell culture products, prioritizing patient health and product quality. OriGen holds ISO 13485 and MDSAP certifications, demonstrating a strong commitment to manufacturing high-quality medical products.

Based in Oak Creek, WI, Owens Industries provides precision machining services for critical components. They specialize in manufacturing parts used in medical devices, equipment, implants, and surgical instruments, leveraging advanced CNC capabilities for complex projects.

Based in Santee, CA, Pathway Medtech is a contract manufacturer and developer specializing in medical devices. They provide a single-source solution for product commercialization, assisting with design, development, market clearance, and manufacturing for the medtech industry.

PEKO Precision Products is a vertically integrated, full-service contract manufacturer of complex machinery, equipment, and precision electromechanical assemblies. They offer NPI, prototyping, sheet metal fabrication, and engineering support. Serving industries like medical, defense, industrial, and semiconductor, PEKO provides comprehensive manufacturing capabilities.

Based in Rocklin, CA, Precision Medical Products, Inc. manufactures and provides innovative mobile medical devices. The company specializes in tubeless and cordless DVT prevention solutions, such as VenaOne® and Circul8 Pro®, designed for acute care and post-surgery recovery. They also offer a range of durable medical equipment.

Precision Molded Plastics Inc, based in Upland, CA, is a high-volume plastic injection molder. The company focuses on manufacturing high-quality plastic products and provides personalized customer service. They offer precision molding capabilities for various industrial applications.

Based in Albion, IN, Precision Medical Industries provides end-to-end molded device manufacturing solutions. The company specializes in silicone handle manufacturing and molded medical components for orthopedic devices, offering design, prototyping, manufacturing, and post-manufacturing support from a single facility.

Based in Roseville, CA, PRIDE Industries is an ISO 13485 and 9001 registered facility, fully complying with FDA regulations. This social enterprise provides competitive business services, including manufacturing, to create employment opportunities for people with disabilities.

Based in Santa Fe Springs, CA, Pro-Tech Design specializes in FDA and ISO 13485 registered medical device contract packaging, assembly, and outsourcing. They offer end-to-end solutions including sewn medical products, laboratory services, and sterilization. Serving medical device manufacturers, the company operates from multiple US facilities.

Based in Santa Clara, CA, ProtoMed Engineering, LLC specializes in design, prototyping, and production services for the medical device industry. They offer high-quality engineering and manufacturing insights for prototype and production components, including precision machining and various design services, committed to customer satisfaction.

Qosina, based in Ronkonkoma, NY, provides medical-grade OEM components to the medical and pharmaceutical industries. Operating from an ISO 13485 certified facility, the company offers a vast inventory of stock components such as clamps, connectors, and valves, with complimentary samples available.

Based in Redwood City, CA, Rapid Axis specializes in medical device prototyping and production services. Their comprehensive capabilities include 3, 4, and 5 Axis CNC machining, 3D printing, DMLS, injection molding, urethane casting, and sheet metal fabrication. They provide competitively priced, quality parts for both prototypes and production runs.

Based in Englewood, CO, Reata Engineering & Machine Works provides comprehensive contract manufacturing services. They specialize in complex machining and electro-mechanical assemblies for medical products, semiconductor, aerospace, defense, and industrial sectors. The company is committed to upholding its ISO 13485 certification.

Based in Baldwin Park, CA, RenyMed is a full-service injection molder providing medical plastics processing. The company offers rapid prototyping, production, and validation services for the Medical Device industry, emphasizing quality engineering and speed-to-market solutions for medical components.

Based in Port Richey, FL, Seaway Plastics is an ISO 13485 certified and FDA registered injection molder. They specialize in thermoplastic and LSR molding, in-house tooling, and cleanroom assembly. Serving medical and highly regulated industries, the company provides low-to-mid volume manufacturing solutions.

Solventum, a spin-off from 3M's healthcare business, specializes in pioneering breakthrough solutions for medical device design engineers. The company manufactures a diverse range of healthcare products including medical wearables, diagnostics, transdermal patches, and dental restoratives, serving the medical and dental industries.

Spartronics provides electronic contract manufacturing services, specializing in PCBAs, subsystem integration, and full-box builds. They offer FDA-registered manufacturing for medical devices and life sciences, alongside support for commercial aerospace, defense, and instrumentation markets.

Springboard Manufacturing is an ISO 13485:2016 certified company specializing in custom plastic injection molding for medical devices. They provide state-of-the-art medical molding and assembly, including overmolding and insert molding, for applications like delivery devices, stents, implants, and sutures. The company offers in-house tooling and design capabilities.

Based in Kalamazoo, MI, Sterling Industries specializes in end-to-end contract development and manufacturing of medical devices and components. They scale production with consistent quality, process, and regulatory compliance. Services include design, supply chain, fabrication, Class 7 cleanroom assembly, QA, and packaging, supporting clients through the entire commercialization process.

Based in San Jose, CA, SunMan Engineering specializes in medical device prototyping, design, and development. They offer custom and rapid prototyping services, leveraging technologies like 3D printing and CNC machining. With expertise in mechanical and electronic disciplines, SunMan assists clients from initial concept through manufacturing.

Based in Macomb, MI, PTI Engineered Plastics is a contract manufacturer providing plastic injection molding services. They specialize in full-service product development for medical, defense, and consumer devices. Capabilities include in-house tooling, scientific molding, and a Class 8 cleanroom, ensuring high-quality plastic part manufacturing.

Tegra Medical offers end-to-end contract manufacturing for medical devices, focusing on precision components and finished devices. They specialize in creating exceptionally sharp tips and implant solutions for orthopedics, spine, and trauma applications. With manufacturing facilities in the United States, the company provides product development support and a quick wire and tubing store.

DesignPlex Biomedical LLC specializes in prototyping, design development, and contract manufacturing of medical devices. The company operates with an ISO 13485 certified Quality System, providing compliant production services for the medical industry.

Based in Dayton, MN, Unity Precision Manufacturing is an ISO 13485 certified contract manufacturer. They specialize in precision machining critical medical components like orthopedic implants and surgical instruments. The company also produces high-performance parts for commercial industries, leveraging CNC machining, turning, wire EDM, and automated quality controls.

Based in Irvine, CA, United Orthopedic Corporation designs, manufactures, and distributes orthopedic implant solutions, including hip, knee, and limb salvage systems. The company focuses on continuously improving its manufacturing processes to deliver high-quality surgical solutions for patients and surgeons, ensuring robust product quality and compliance.

U.S. Precision Sheet Metal, Inc. provides advanced CNC manufacturing services, including laser cutting, machining, metal forming, welding, and kitting. Based in Riverside, CA, they specialize in precision parts for the Medical, Aerospace and Defense, and Electronics/Communications industries, offering comprehensive quality control for demanding applications.

Vantagemedtech is an FDA registered and ISO13485 certified contract manufacturer, specializing in medical device and MedTech solutions. The company ensures high-quality production through rigorous testing and processes. With offices in Lyndhurst, NJ, and Lenexa, KS, and a manufacturing facility in Lenexa, KS, it serves the US market.

VSE is a US-based contract manufacturer specializing in PCBA and electronic assembly services. They provide custom PCBA, wiring, cable assembly, and box build solutions for medical technology and other industries. With manufacturing facilities in California and Nevada, VSE delivers precision electronic product manufacturing.

Based in Warsaw, IN, Zimmer Biomet is a global manufacturer of innovative medical technology. They provide implants and digital solutions aimed at enhancing patient mobility, joint health, and overall wellness. The company supports individuals throughout their recovery journey with advanced medical devices.

Creanova is an ISO 13485 registered company offering medical device design, development, and contract manufacturing. They provide comprehensive healthcare solutions, guiding clients from conceptualization to market-ready medical devices through a structured, customizable process. Their expertise ensures innovative solutions for improved quality of life.

HPPI offers precision CNC machining services for low and high-volume production in medical device, aerospace, and biotechnology industries. The company is ISO 13485:2016 certified and FDA registered, providing advanced milling and turning operations. They focus on delivering consistent quality and optimizing manufacturing processes.

Saint-Gobain Medical designs, develops, and manufactures custom medical components and engineered systems for medical devices. They specialize in creating critical parts and assemblies, leveraging expertise in material science and precision engineering to meet the demanding quality and innovation requirements of the healthcare industry.

Based in Charlton, MA, MTD Micro Molding specializes in manufacturing micro medical components and bioabsorbable implants. The company provides micro molding, tooling, metrology, assembly, and prototyping services. They are ISO 13485:2016 certified and FDA Registered.

Stryker is a medical technology company that manufactures a wide range of products for the healthcare industry. They serve customers globally, impacting millions of patients each year with innovative medical solutions.

Based in Richmond, TX, Velentium Medical is a professional engineering firm specializing in the design and manufacturing of Class II and Class III medical devices. The company provides comprehensive services including medical device R&D, manufacturing, cybersecurity, and test system development, aimed at transforming intellectual property into safe and secure products.

Based in Fremont, CA, A&D Precision Inc. is an ISO 13485:2016 certified contract manufacturer for medical devices. They offer precision machining, clean room assembly (Class 1,000 and 10,000), design assistance, and field service support. A&D serves medical, life science, and semiconductor industries with comprehensive solutions.

Based in San Jose, CA, Apex Machining is an ISO 13485 certified contract manufacturer. The company specializes in precision machining of mission-critical and safety-critical components for large Silicon Valley OEMs. Apex has extensive experience producing complex geometries from difficult-to-machine materials.

Based in Carlsbad, CA, Argonaut Manufacturing Services is a contract manufacturing organization specializing in pharmaceutical, diagnostic (IVD), and life science products. They offer aseptic and non-aseptic drug fill-finish, lyophilization, and drug-device combination product manufacturing. The company also provides comprehensive analytical and quality control support.

Based in Hutto, TX, A.R. Machining Inc. is a precision CNC machine shop established in 1979. They specialize in manufacturing highly precise medical machined components, including ventilators and various medical devices. They also serve aerospace, semiconductor, military, and energy industries.

AVNA manufactures components for medical devices, operating with multiple locations in the United States and Costa Rica. The company focuses on innovative solutions and collaboration, aiming to deliver excellence and expedite the market entry of medical devices for precision applications.

BMP Medical is a US-based custom plastic contract manufacturing partner specializing in precision medical manufacturing and assembly for OEMs. They offer injection molding, injection blow molding, cleanroom manufacturing, and process validation for medical device components and IVD devices.

C.G. Laboratories, Inc. provides ISO 13485:2016 certified laboratory testing, sterilization validation, decontamination, and contract packaging services for the medical device industry. Based in Granbury, TX, the company offers environmental monitoring and consulting, leveraging over 90 years of collective team experience.

DEM Medical provides integrated medical device manufacturing, from concept through production. Their in-house capabilities include design, engineering, rapid prototyping, PCBAs, and injection molding. Operating from U.S.-based facilities, DEM delivers high-precision products, adhering to strict industry standards for medical devices.

Based in Tustin, CA, DeviceLab Inc. specializes in medical device development, prototyping, and pilot production using in-house fabrication capabilities. They offer comprehensive engineering services including industrial design, mechanical, systems and electronics, and medical device software design. DeviceLab serves medical companies nationwide.

EB Industries, based in Farmingdale, NY, provides precision electron beam welding and laser hermetic sealing services. They expertly join a wide range of common and exotic materials, including dissimilar combinations. Their high-quality welds and seals are crucial for mission-critical components in industries like medical devices, semiconductor, and aerospace.

Based in Hartland, WI, Fathom Manufacturing offers advanced prototyping and production manufacturing services from multiple US facilities. They specialize in medical device components like enclosures, surgical tools, orthopedic implants, and spinal screws. Core capabilities include 3D printing, CNC machining, injection molding, urethane casting, and comprehensive assembly and finishing.

Forum is an ISO 13485 certified contract manufacturer specializing in medical injection molding and assembly. They operate an ISO Class 7 cleanroom, providing micro, insert, and over molding. With over 30 years of experience, Forum offers prototyping, laser marking, and pad printing for the medical industry.

Gilero partners with global healthcare companies, specializing in the development of innovative medical devices and drug delivery systems. They offer tailored solutions from initial concept through to global-scale production, ensuring comprehensive support for medtech innovation and commercialization.

Based in Manitowoc, WI, Kaysun Corporation, Inc. specializes in custom injection molding for complex applications, defined by engineered excellence. They partner with manufacturers to provide full-service solutions and process efficiencies, with a commitment to environmental stewardship.

Keller Technology Corporation manufactures specialized medical equipment for medical device systems. The company also produces equipment for pharmaceutical, biopharmaceutical, and radiopharmaceutical applications, serving industrial and commercial B2B clients in the life sciences sector.

Based in Jasper, IN, Kimball Electronics provides comprehensive Electronics Manufacturing Services (EMS) and Contract Manufacturing Organization (CMO) solutions. Specializing in medical solutions, the company offers engineering and design services, leveraging a global footprint and core competencies to deliver quality manufacturing services for complex electronic products.

MFG One is an ISO 13485 certified electronic contract manufacturer based in Chantilly, VA. The company provides comprehensive box build services, including design, sourcing, assembly, and fulfillment with U.S.-based execution. They serve industries like medical devices, biotechnology, and electronics, delivering consistent product performance.

Based in East Aurora, NY, Moog provides advanced motion control solutions, including both hardware and software, for medical OEM customers globally. The company specializes in creating innovative medical technologies, offering electric, hydraulic, and electro-hydrostatic solutions to solve complex motion control problems.

Nissha Medical Technologies provides design and manufacturing solutions for single-use medical technologies. The company produces patient monitoring and medical surgical consumables, offering private label products for healthcare providers. With manufacturing facilities in Sandpoint, ID, and Buffalo, NY, it serves global clients.

Based in Westlake, OH, Nordson Medical is a global expert in precision engineering, developing, and manufacturing complex medical devices and components. The company provides specialized solutions for the healthcare industry, focusing on creating life-changing products and medical device components.

Based in Holt, MI, Orchid Orthopedic Solutions specializes in contract manufacturing for medical devices, focusing on implant procedures for major orthopedic markets. The company provides solutions for hip, knee, and spine reconstruction, helping clients develop and bring their medical products to life.

Based in Reno, NV, Orthopaedic Implant Company (OIC) manufactures high-value orthopaedic implants. OIC specializes in devices for ankle, hand/wrist, hip fractures, IM nails, plates and screws, and sports medicine, offering cost-effective, quality solutions.

Precision Medical, Inc. specializes in the manufacture of respiratory medical devices and related products. The company produces a range of essential medical equipment including flowmeters, vacuum regulators, medical blenders, aspirators, and medical air compressors. They also provide fittings and hose configurators for various medical applications, serving the healthcare industry.

Based in Warsaw, IN, Precision Medical Technologies is an ISO 13485:2016 certified contract manufacturer specializing in orthopedic and minimally invasive surgery devices. They offer end-to-end services, from design for manufacturability and prototyping to high-volume production and sterile packaging.

Based in Alpharetta, GA, Remington Medical provides full-service medical device contract manufacturing. With over 30 years of experience, the company offers comprehensive solutions from concept to finished product. They specialize in producing medical devices, focusing on quality and regulatory compliance for their clients.

Based in Allentown, PA, Sanbor Medical offers integrated contract manufacturing for medical devices and life sciences. They specialize in product design, injection molding, extrusion, assembly, and sterilization management. As an ISO 13485:2016 certified and FDA registered manufacturer, the company provides comprehensive production solutions.

SMC Ltd. provides contract manufacturing for single-use medical devices and comprehensive pharma solutions. With over 35 years of experience, the company offers sterile filling, development services, and analytical support. They specialize in custom solutions for intricate surgical tools, advanced biopsy, and injection devices, ensuring precision and expedited production.

Spectrum Plastics Group specializes in the design, development, and manufacturing of specialty medical components and devices. They offer extensive expertise in applications such as extruded tubing, catheter technologies, and medical balloons, providing both standard and custom solutions. The company partners with teams from initial ideas through final product delivery.

Based in Corona, CA, Tamshell Corporation operates a 33,000 sq. ft. precision machine shop. The company is ISO 13485 certified, providing specialized manufacturing services for medical devices. They also hold AS9100D and ISO 9001 certifications, offering state-of-the-art machining capabilities for various industries.

ARRK offers comprehensive product development services, from rapid prototyping to custom manufacturing and production. The company specializes in advanced medical device prototyping solutions, adhering to ISO-certified quality standards and providing expert engineering support. ARRK collaborates with clients to streamline the product development process and accelerate market entry for new designs.

Based in Woodbury, MN, VitaTek provides comprehensive medical device development and manufacturing services. They offer rapid prototyping and leverage vertical integration with in-house specialists for engineering, regulatory, and production. VitaTek aims to accelerate projects, reducing R&D fees and time-to-market for medical innovators.

Based in Livermore, CA, Westec Plastics is an ISO 13485:2016 certified plastic injection molding manufacturer. They specialize in precision plastic components with clean room capabilities for medical, aerospace, consumer, baby care, and veterinary industries. The company also offers comprehensive mold building and secondary operations.

Evolve Manufacturing specializes in producing complex medical and life sciences devices and instruments. Located in Silicon Valley, the company operates a 75,000 sq ft facility dedicated to high-precision manufacturing. They provide comprehensive solutions for the healthcare and life sciences sectors, ensuring quality and advanced production capabilities.

Ezurio provides wireless modules, system on modules (SOMs), single board computers, and design services. Their US-based manufacturing facility in Irvine, CA, operates under an ISO 13485:2016 compliant quality management system. They offer secure connectivity solutions for demanding medical, industrial, and commercial applications, including FIPS certified devices for patient monitoring.

Freudenberg Medical is a Contract Development and Manufacturing Organization (CDMO) for innovative medical components and devices. They provide end-to-end support from design to series manufacturing, with vertically integrated capabilities in precision molding, extrusion, and various advanced materials for the medical and pharma industries.

Based in Southampton, PA, GMi Corp offers precision medical manufacturing, specializing in CNC machining, milling, and turning for complex medical devices, components, and instruments. Handling projects from prototyping to production, they ensure high-quality, meticulous precision. GMi Corp is ISO 13485:2016 certified and FDA registered for the medical industry.

Golden Valley Products (GVP) is an experienced OEM medical device manufacturer specializing in custom manufactured medical products. Based in California, the company provides high-quality solutions for the medical industry, leveraging its skilled team for precision manufacturing services and product development.

HDA Technology specializes in creating and building medical devices for clients across the country. Based in Southern California, the company provides comprehensive manufacturing services designed for the medical device industry, focusing on quality and regulatory compliance to meet client needs.

Medical Components of America manufactures small, precision medical parts, focusing on achieving the lowest possible cost while meeting the highest quality standards. The company's product realization process is entirely centered around this specialized business model, emphasizing ethical practices and a defined scope to optimize operations.

Based in Pierceton, IN, Paragon Medical specializes in advanced medical manufacturing and design services. The company produces a wide range of medical devices, components, and products, catering to the specific needs of the healthcare industry. They operate multiple manufacturing facilities across the United States.

Contract Medical Manufacturing LLC, based in Oxford, CT, provides specialized contract manufacturing services for the medical device industry. The company focuses on producing precision components and assemblies for healthcare applications, operating with quality management systems essential for regulated medical products.

ReNEW Manufacturing Solutions provides custom metal parts for the medical industry, including medical devices, surgical tools, and diagnostic systems. With four U.S. locations, they offer comprehensive in-house machining, fabrication, welding, and finishing services, ensuring precision and fast delivery.

Rev1 Engineering is an ISO 13485 certified medical device engineering and product development firm based in Temecula, CA. They specialize in transforming concepts into functional prototypes and finished medical technologies. Services include product design, rapid prototyping, machining, testing, and manufacturing operations support.

Based in Austin, TX, Lor-Van Manufacturing provides turnkey fabrication and assembly services for high-value, high-complexity, precision machined metal components. As part of the Texas Contract Manufacturing group, the company is certified to ISO 13485 for Medical Devices Quality Management. They ensure quality and reliability in manufacturing for the medical sector.

Viant is a design and manufacturing partner specializing in medical devices for OEMs. The company provides comprehensive manufacturing capabilities for various MedTech solutions, including interventional and inhalation devices. They focus on delivering product quality and speed to market for medical technology.