Medical Device Assembly Companies

Based in San Marcos, CA, ACI Medical, LLC provides contract manufacturing and engineering services, specializing in medical device assembly and components. Capabilities include custom plastic molding and miniature diaphragm pump manufacturing. They focus on delivering quality, cost-effective solutions for clients, ensuring on-time project completion.

Based in Houston, TX, AJ Medical Manufacturing is an ISO 13485 and FDA registered contract manufacturer. They specialize in medical device and component manufacturing, offering vertically integrated solutions to customer partners. Their services encompass medical device design and production, aimed at reducing time to market and inventory costs for clients.

Anzer USA, based in Akron, OH, provides ISO 13485 certified medical electronics assembly services. The company specializes in precision medical PCB assembly, ensuring compliance, quality, and traceability for electronic components used in advanced healthcare technologies and medical devices, focusing on risk management.

Applied Medical is a global medical device company focused on developing breakthrough technologies for Minimally Invasive, General, Bariatric, and Cardiac Surgery. Through a vertically integrated business model, they aim to enhance clinical care and improve the accessibility and affordability of high-quality healthcare worldwide.

Based near Cleveland, OH, Applied Medical Technology, Inc. designs, engineers, and manufactures enteral feeding devices and surgical products. Since 1985, the company has focused on developing and manufacturing medical devices with high standards for performance and quality, committed to patient care.

ARCH Medical Solutions offers contract manufacturing and supply chain integration for medical OEMs. They specialize in producing orthopedic, spine, dental, and surgical robotics devices, including implants and instruments. The company utilizes advanced CNC and additive manufacturing at FDA-registered facilities nationwide for comprehensive medical device production.

Atalys provides vertically integrated contract manufacturing services for advanced medical devices, offering comprehensive end-to-end solutions. Capabilities include highly engineered tooling design, extreme precision plastic injection molding, and cost-effective automation with assembly options for critical surgical applications.

Based in Salt Lake City, UT, Biomerics is a medical device contract manufacturer providing end-to-end capabilities. They offer design services, material expertise, engineered components, and finished device assembly for complex interventional medical products. With vertical integration and custom polymer compounding, Biomerics supports efficient development and market entry.

Based in Houston, TX, Biotex Inc. is an ISO-certified, FDA-registered CDMO. The company specializes in medical device design, engineering, and manufacturing, which includes assembly services. Leveraging over 25 years of expertise, Biotex transforms innovative ideas into groundbreaking medical solutions, supporting development through commercialization.

Based in Conroe, TX, NovoSci Corp. provides medical device contract manufacturing, specializing in single-use, sterile products for cardiovascular and general surgery. They offer Class 7 cleanroom assembly using methods like ultrasonic welding and adhesive bonding. Services include custom tubing packs, packaging, and distribution. NovoSci is ISO 13485:2016 certified.

Cretex Medical specializes in critical medical device assembly and kitting, managing projects from components to finished devices. They offer complete device assemblies, sub-assemblies, and sterile packaging. Operating in Class 7 and Class 8 cleanrooms, they serve industries like orthopaedics, surgical instruments, and cardiac rhythm management.

Based in San Diego, CA, D&K Engineering, Inc. provides medical device product design and full-service contract manufacturing. Their ISO 13485 certified and FDA registered facilities ensure products meet stringent regulatory requirements from pre-clinical through post-market surveillance. They support various medical devices, equipment, and machinery.

Nissha Medical Technologies, based in Buffalo, NY, specializes in end-to-end design, development, and manufacturing of single-use medical technologies. They offer contract manufacturing services, accelerator programs for product development, and agile production planning. Their capabilities include isometric micro molding and a clinical wearables lab, supporting advanced medical product realization.

Domico Med-Device LLC provides contract manufacturing services for the medical industry, supplying products, accessories, and components to OEMs. They offer integrated solutions from product design to full-scale production, utilizing diverse technologies like carbon fiber, sewing, and sealing. The company is FDA Registered and ISO 13485:2016 certified.

Based in Bartlett, TN, Engineered Medical Systems, LLC (EMS) provides full-service contract manufacturing for complex medical instrumentation and implants. Operating from a 100,000 sq ft facility, EMS offers prototype design, verification/validation, and production manufacturing. They emphasize precision, quality, and dedicated capacity for medical device assembly.

Based in Malta, OH, EZG provides custom contract manufacturing services since 1998. They specialize in producing custom parts and mechanical assemblies for demanding industries, including medical equipment, oil and gas, and food processing. Their 185,000 sq.ft. facility handles processes from prototyping to full production runs.

Integer is a global medical device contract manufacturer offering comprehensive design, development, manufacturing, and assembly services. With over 80 years of experience, the company specializes in producing cutting-edge medical devices. They serve original equipment manufacturers across various therapeutic areas from their extensive network of facilities.

Based in Millbury, OH, Levison Enterprises is an experienced medical device contract manufacturer specializing in electronic medical devices. The company provides comprehensive services including design, engineering, prototyping, testing, and production of medical device products, parts, and components, helping clients bring their concepts to market-ready products.

Lighteum Medical, based in San Diego, CA, specializes in rapid development and quick-turn prototyping for complex medical device components. The company provides on-site engineering support and efficient processing of intricate parts. Maintaining a significant inventory of nitinol tubing, Lighteum Medical accelerates projects across various stages of medical device development.

Marshall Manufacturing is a contract medical device manufacturer based in Minneapolis, MN. They offer precision CNC machining, laser cutting, welding, bending, and assembly services. The company specializes in producing medical devices, implants, and instruments for the medical industry.

Based in Carlsbad, CA, Means Engineering, Inc. is a contract manufacturer specializing in product development, design, production, and testing services. The company provides turn-key solutions for medical, industrial, semiconductor equipment, and military products, guiding clients from concept to market.

Based in San Jose, CA, Medeologix, Inc. is a medical device manufacturer specializing in catheters, medical balloons, and PET heat shrink tubing. They provide comprehensive development and manufacturing services, bringing life-enhancing products to market through their extensive expertise in mass production.

Based in Grand Rapids, MI, Medisurge offers complete U.S.-based medical device manufacturing for OEMs. The company provides engineering support, sterilization, and distribution services. Medisurge partners with clients from concept through to the final distribution of their medical devices.

Based in Pearland, TX, Merit Medical operates a state-of-the-art facility with 300 employees specializing in medical device technology. The company offers outstanding manufacturing capabilities, delivering cutting-edge medical devices from start to finish. This site is recognized as a Center of Excellence for medical device manufacturing.

Based in Richfield, WI, MGS delivers end-to-end medical device contract manufacturing solutions. The company specializes in serving innovators within the MedTech and surgical product sectors, offering comprehensive services to guide products from development through assembly and beyond.

Based in Somerset, NJ, Micro is an FDA and ISO 13485 certified contract manufacturer. The company specializes in finished medical devices and complex handheld assembly, offering end-to-end solutions from concept to full-scale production. It provides R&D engineering, precision tube fabrication, and advanced automation.

Millstone Medical Outsourcing provides comprehensive packaging, assembly, and testing services for medical device manufacturers. They specialize in quality critical inspection, set building, finished goods distribution, and validation engineering. The company operates a 25,000-square-foot facility with extensive in-house, ISO 17025 certified laboratory testing operations.

MRPC offers specialized molding and assembly services for medical devices. They operate multiple clean rooms, providing a controlled and certified environment essential for the production of critical medical components and products.

NextPhase Medical Devices LLC, based in Mansfield, MA, specializes in contract manufacturing for complex electromechanical and single-use disposable medical devices. Offering low- to medium-volume production, their ISO 13485 certified, FDA registered facilities feature cGMP compliant Class 7 & 8 clean rooms, exclusively serving the medical industry.

Norman Noble, Inc. specializes in advanced medical device manufacturing for challenging vascular and orthopedic implants. They utilize sophisticated laser processing, 5-axis micro milling, and turning capabilities to produce complex components such as nitinol stents, heart valve parts, extremity screws, and spine cages, offering comprehensive device fabrication.

Based in Dayton, OH, Norwood Medical provides precision medical device manufacturing services, including post-processing and assembly. With nearly a century of experience, the company serves demanding markets such as cardiovascular, minimally invasive surgery, orthopedics, robotic-assisted surgery, and other surgical technologies.

Based in Santee, CA, Pathway Medtech is a medical device design and development contract manufacturing company. They offer comprehensive services for medical device projects, ensuring full compliance with FDA and ISO 13485 certifications. The company focuses on bringing innovative medical devices from concept to market efficiently and reliably.

Based in Rochester, NY, Peko Precision offers comprehensive contract manufacturing and assembly services for medical OEMs. They produce complete finished devices, critical subsystems, and complex components for Class I and II medical equipment, including imaging, diagnostics, and laboratory automation tools. Peko provides precision engineering and manufacturing excellence for various medical technologies.

Based in Avon Lake, OH, Pilgrim Harp offers medical contract manufacturing for components and multi-component assemblies. Capabilities include CNC machining, castings, forgings, stampings, and injection molding. The company manages all production steps for medical device requirements, ensuring quality standards with ISO 9001:2015 certification.

Based in Solana Beach, CA, PiSA USA is a contract manufacturer for medical devices. They specialize in manual and automated assembly, injection molding, tubing and film extrusion, RF welding, and ETO sterilization. The company provides comprehensive services including product development and design for manufacturing.

Based in Roseville, CA, PRIDE Industries offers comprehensive medical device manufacturing services. Their skilled engineers and technicians ensure products like saliva test kits and active pressure therapy machines meet stringent standards. They specialize in delivering high-quality, perfectly functioning medical devices for their customers.

Based in Stoughton, MA, Primo Medical Group specializes in medical device assembly services. They provide quality-controlled, cleanroom assembly for critical devices and equipment. The company also performs precision CNC machining for medical components, managing sourcing and manufacturing to produce finished products for the medical industry.

Based in Tustin, CA, Pro-Dex, Inc. specializes in the design and manufacturing of medical devices and healthcare products. The company operates a dedicated manufacturing facility, providing comprehensive services for the medical device and healthcare industry.

Pro-Tech Design & Manufacturing, Inc. based in Santa Fe Springs, CA, offers full-service medical device contract assembly. The ISO 13485 certified company provides over 10,000 square feet of Class 10,000/ISO 7-rated cleanroom space. Their capabilities encompass medical device assembly, packaging, and kitting services for various products.

Based in Santa Clara, CA, ProtoMed Engineering, LLC provides design, prototyping, and production services specifically for the medical device industry. The company offers precision machining and supports both large and small medical device companies with their manufacturing needs.

Resonetics specializes in quick-turn prototyping of medical device components and complex sub-assemblies for MedTech customers. Their LightSpeed Labs develop scalable manufacturing processes, enabling rapid product development and high-volume production. They have a global network of specialized teams and advanced technologies.

Based in Los Angeles, CA, Roberson Machine Company specializes in innovative medical device manufacturing. They provide precision CNC machining services, including milling and turning, for high-volume production of critical components. The company assists medical professionals in meeting demanding needs, ensuring product quality.

Spartronics provides ISO 13485 certified medical device manufacturing services, specializing in FDA-compliant production and expert lifecycle management for life-sustaining devices. They offer comprehensive support including multi-disciplinary development, technical engineering, and regulatory compliance. The company focuses on reliability, quality, traceability, and document control.

Based in Yorba Linda, CA, SpecialTeam is an FDA registered and ISO 13485:2016 certified full-service medical device contract manufacturer. The company specializes in providing comprehensive manufacturing and assembly services for medical devices, ensuring compliance with industry standards.

Based in Kalamazoo, MI, Sterling Industries specializes in medical device assembly and custom component manufacturing for approved medical devices. They provide comprehensive services including sterilization compliance, in-process and post-assembly testing, and packaging. Utilizing Class 7 Clean Rooms and automation, they ensure precision and repeatability in high-volume projects.

Based in Palm Beach, FL, SYNEO provides contract manufacturing services for minimally-invasive medical devices. They specialize in automation for cutting, feeding, slitting, flaring, grinding, skiving, printing, punching, and assembly of device components like catheters and guide wires, as well as cutting human tissue.

Tegra Medical provides end-to-end contract manufacturing services for complete finished medical devices and complex components. The company specializes in creating precision-engineered instruments and implant solutions for orthopedics, spine, and trauma applications, including exceptionally sharp tips. It offers product development support and operates manufacturing facilities across the United States.

Based in Brookfield, WI, Trace-A-Matic Corporation provides comprehensive contract manufacturing services for the medical device industry. They leverage advanced capabilities to produce high-quality medical device components, adhering to stringent regulatory requirements. The company prioritizes rigorous quality control and inspection protocols throughout production.

Based in Dayton, MN, Unity Precision Manufacturing specializes in turnkey contract medical device production and manufacturing services. They offer DFM support, prototyping, full-scale production, assembly, and distribution. The company is FDA registered, and maintains ISO 9001 and 13485 certifications, serving OEMs and Medtech startups.

Vantage Medtech is an FDA registered and ISO13485 certified contract manufacturer specializing in medical device assembly. They provide integrated manufacturing solutions for small and large-scale builds, offering engineering support, production scalability, and global distribution. Services include supply chain management and device servicing from their US facilities.

Based in Grand Island, NY, Fresenius Kabi Contract Manufacturing provides full-service solutions for developing and manufacturing sterile injectables and medical devices. They offer expertise in formulation, process implementation, aseptic processing, and terminal sterilization, with comprehensive filling and finishing for clinical and commercial use.

Tecomet provides innovative medical manufacturing solutions, leveraging technical expertise and precision to meet complex needs. Their services span from design prototyping to full-scale production, including inventory management and sterile cleanroom assembly. They partner with leading medical companies, ensuring quality across all stages of production.

Telemade is a Texas-based contract manufacturing supplier specializing in medical equipment and biomedical assembly. From its 30,000+ sq ft facility, the company offers material cutting, in-house sewing, RF welding, foam fabrication, vacuum forming, product component manufacturing, and packaging solutions.

Based in Richmond, TX, Velentium Medical is a professional engineering firm that designs and manufactures Class II and Class III medical devices. The company transforms intellectual property into safe, secure products, providing comprehensive medical device manufacturing, R&D, cybersecurity, and test system services.

Based in Fremont, CA, A&D Precision Inc. specializes in medical device manufacturing for the healthcare industry. They offer precision machining, assembly, component inspection, packaging, and sterilization validation for high-mix, low-volume production. The ISO 13485 certified company also provides material procurement and comprehensive supply chain management.

Based in Eastlake, OH, Astro Manufacturing & Design produces components and assemblies for the medical device and equipment industries. They manufacture custom health monitoring and turnkey medical simulator systems for training. The company also supplies OEM and service parts for PET, CT, MRI, and Nuclear systems.

Based in Sterling, MA, BMP Medical is an OEM contract manufacturer providing services for the medical device industry. The company specializes in highly precise plastic injection molding, cleanroom manufacturing, and assembly. Capabilities include design, development, packaging, and process validation for IVD components and devices.

Based in Ormond Beach, FL, Command Medical specializes in customized medical device assembly and packaging for the medical and life science industries. They provide sub-assembly, sterile and non-sterile device production, and high-volume product transfers. Services include RF welding, tube extrusion, and sterilization management, ensuring precision and compliance.

DEM Manufacturing is an FDA-registered manufacturer specializing in medical device engineering, prototyping, and production. They provide scalable manufacturing solutions, developing assembly processes and high-volume tooling for medium-volume runs. Their robust QMS ensures quality, meeting stringent regulatory requirements for medical devices.

Based in Fremont, CA, Evolve Manufacturing is an ISO 13485 certified contract manufacturer for medical devices, diagnostics, and life sciences. They offer precision machining, injection molding, and advanced cleanroom assembly and testing services for Class I, II, and III medical devices, from prototyping to high-volume production needs.

Based in Waco, TX, Foamtec Medical offers contract and custom medical device manufacturing. Services include R&D, fabrication, and kitting with expert assembly, specializing in PU foam components. They serve industries such as diagnostics, respiratory, orthopedics, and drug delivery, operating as an FDA-registered facility.

Based in Durham, NC, Gilero partners with healthcare companies to develop medical devices and drug delivery systems. They provide comprehensive services from concept to global-scale production and commercialization, encompassing the full product development lifecycle for innovative medtech solutions.

Keller Technology specializes in custom manufacturing and high-level assembly of medical equipment, including diagnostic instruments and device systems. The company produces specialized equipment for various medical sectors, including pharmaceuticals, biopharmaceuticals, radiopharmaceuticals, and general healthcare.

Based in Jasper, IN, Kimball Electronics provides comprehensive medical product assembly services. Its Medical Solutions division specializes in medical electronics manufacturing, scientific injection molding, clean room, and automated assembly. Capabilities include combination products and connected medical devices, offering end-to-end solutions from design engineering to sterilization.

Based in Minneapolis, MN, MDI specializes in contract medical device assembly and packaging services for healthcare sector and OEM manufacturers. They provide domestic medical device kitting and assembly with expert precision and reliability. MDI is ISO 13485 certified and FDA registered, ensuring adherence to high industry standards.

Based in Akron, OH, Metalcraft Solutions offers ISO 13485 certified precision medical device and component manufacturing. Capabilities include additive manufacturing (DMLS), 3- and 5-axis machining, Wire EDM, Swiss turning, and laser cutting. They also provide in-house heat treating, finishing, and polishing for high-quality medical production.

Remington Medical, based in Alpharetta, GA, provides full-service medical device contract manufacturing solutions. They specialize in designing and developing high-quality, disposable medical devices for various fields like cardiology, oncology, and urology, offering services from concept to delivery.

Resolution Medical, based in Fridley, MN, specializes in the development and manufacture of complex medical devices. The company provides end-to-end manufacturing services for catheter delivery systems, active implantables, and component manufacturing. Services encompass clean rooms, sterile packaging, and support for production runs from small to commercial scale.

Based in Temecula, CA, Rev.1 Engineering is a medical device development company. They specialize in design and development, validation testing, and early-stage manufacturing for medical devices, offering capabilities that include assembly services for new product introduction.

Based in Denver, PA, Röchling Medical Lancaster is a vertically integrated contract manufacturer specializing in complex medical devices. They provide cleanroom injection molding, metal processing, and precision assembly services. The company aims to simplify supply chains and improve process flow for their medical device customers.

Based in Allentown, PA, Sanbor Medical is a medical device assembly company with over 30 years of production experience. The company leverages its global manufacturing footprint to offer competitive services and pricing, specializing in high-quality manufacturing and assembly solutions for the medical industry.

Shawmut Corporation specializes in contract medical device manufacturing and component assembly. With FDA Registered Facilities and ISO9001 certification, they offer outsourced manufacturing, custom materials design, and innovative materials development. They support medical manufacturing projects from parts through full production, including supply chain reshoring.

Spectrum Plastics Group specializes in the design, development, and manufacturing of specialty medical components. They provide both standard and custom solutions, leveraging expertise in medical device applications. Their capabilities include extruded tubing, catheter technologies, and medical balloons, supporting projects from concept to final product.

UFP MedTech is a full-service medical device company that accelerates single-use and single-patient devices from development through manufacturing. They specialize in sterile packaging and producing various medical device components, such as foam parts and surgical bed surfaces. The company directly provides medical device assembly services at its U.S. facilities.

Based in San Diego, CA, ARRK North America, Inc. provides comprehensive product development and manufacturing services. The company specializes in bringing design files to life, offering expertise in materializing ideas into functional products. They explicitly cater to the medical device industry, assisting clients in developing and producing their devices.

Freudenberg Medical is a CDMO partner specializing in designing, developing, and manufacturing medical devices and components. They offer vertically integrated capabilities, from ideation to series production, including precision molding, extrusion, and minimally invasive device manufacturing. Their deep materials expertise supports complex projects for the medical and pharmaceutical sectors.

HDA Technology specializes in creating and building medical devices for clients. The company provides comprehensive medical device assembly services, serving customers across the United States. They focus on manufacturing solutions for the medical industry from their facilities in Southern California.

Paragon Medical is a global medical device contract manufacturer specializing in design, development, and manufacturing services for medical device OEMs. They offer comprehensive capabilities including precision machining, additive manufacturing, sterilization, and advanced assembly and packaging, including cleanroom assembly, across multiple US facilities.

Based in Norcross, GA, ReNEW Manufacturing Solutions provides American-made, build-to-print metal parts and custom fabrication for the medical industry. They specialize in high-precision components and welded assemblies for medical devices, surgical tools, and diagnostic systems, offering prototyping to production from their US facilities.

SHL Medical, based in Deerfield Beach, FL, provides expert medical device assembly services, specializing in drug delivery systems. They offer complete final assembly, labeling, and packaging services, ensuring high quality standards for various drug delivery devices with facilities in the US.

Based in Austin, TX, Texas Contract Manufacturing Group (TCMG) provides end-to-end manufacturing solutions for medical device projects. They specialize in high-precision machining, producing intricate components with precise tolerances. TCMG supports companies from prototyping to large-scale production, ensuring optimal performance for critical healthcare applications.

Veranex Inc. is a medical device contract manufacturer providing flexible, integrated manufacturing and supply chain expertise. They support projects from early development through commercial production, including clinical trial builds. Veranex serves diverse medical device sectors such as cardiovascular, digital health, in-vitro diagnostics, neurovascular, and ophthalmology.

Viant Medical specializes in comprehensive design, development, fabrication, and assembly services for medical devices. The company offers reliable and efficient production capabilities, catering to diverse healthcare requirements. With extensive manufacturing expertise, Viant Medical supports clients in bringing complex medical innovations to market.