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Advanced Scientifics Advanced Scientifics Inc. is a fully integrated, FDA registered, ISO 13485:2003 certified contract manufacturer of class I and II Disposable Medical Devices, specializing in fluid management. From product design/prototyping to finished sterile packaging, ASI is your complete resource for contract manufacturing of high quality, medical disposables. Web: www.advancedscientifics.com |
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Applied Manufacturing Technologies Inc. Our objective is to meet or exceed your particular requirements by offering the best quality of contract manufacturing services which include: Laser Marking, Coding and Engraving, Pad Printing, Catheter Printing, Inkjet Printing, Hot Stamping & Heat Transfer, Corona & Plasma Treating and Ultrasonic Welding. Let us be your reliable out-source Manufacturer that makes your company more competitive and more profitable. Web: www.amtecinc.com |
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Asahi Intecc ASAHI INTECC develops and supplies wire materials and products to the industries inside and outside Japan using an integrated in-house production system based on our four advanced core technologies that covers everything from selection and treatment of raw materials to manufacture of final products. In the medical field, ASAHI INTECC develops, manufactures and assembles OEM related products, such as guidewires and catheters. Web: www.asahi-intecc.com |
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Aubrey Group, Inc. Aubrey Group, Inc. in Irvine, CA specializes in design, development and manufacture of therapeutic, surgical and diagnostic medical devices. Services include system design, electronics, software and mechanical engineering, V&V, compliance testing, prototypes, manufacturing and clean room. Expertise includes RF generators, wireless, microfludics, implantables, and disposables. ISO 13485 Certified, FDA Registered. Web: www.aubreygroup.com |
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B Braun OEM Division, B. Braun Medical, Inc. The B. Braun OEM Division delivers complete contract manufacturing capabilities, focusing on Class II and Class III medical devices. The company manufactures thousands of standard and specialty items from components to custom trays. Services available include research and development, design, prototyping, tooling, molding, validation, manufacturing, packaging, sterilization, quality control, private labeling and regulatory guidance. Web: www.bbraunoem.com |
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Command Medical Products Command Medical Products, Inc. offers bag manufacturing, tube extrusion, assembly and packaging services from both their Florida and Nicaragua facilities. Both facilities are registered with the FDA and are ISO 13485 certified. Cleanroom and white room manufacturing area are available. Additional services include turnkey sourcing, kanban inventory solutions and sterilization management. For more information contact sales@commandmedical.com Web: www.commandmedical.com |
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Covidien The Covidien OEM and Custom Product Solutions Division is dedicated to delivering high quality medical and custom engineering products to the Medical Device, Pharmaceutical, Consumer, Rehabilitation, and Industrial Markets. Drawing from the diverse manufacturing capabilities of 67 manufacturing facilities worldwide, Covidien OEM offers our customers and partners a single source for custom product design and development, and of the broadest standard product offerings in the medical device industry today. Web: www.covidien.com |
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DDL, Inc. DDL’s technical experts are industry leaders in medical device package, product and material validation (ISO 11607) and can help ensure that you comply with industry standards and regulations. DDL offers a full range of testing service from accelerated aging, shelf-life studies and microbial barrier testing to distribution simulations and package integrity and strength and material characterization testing. DDL offers quick turnaround time, accurate reports and excellent customer service. Our new facility in Fountain Valley, CA also includes a design center to help you with rapid time to market for package design. To better serve you, DDL also has labs located in Minnesota and New Jersey! Web: www.testedandproven.com |
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Donatelle Donatelle is an FDA compliant, ISO-9001:2000 and ISO-13485:2003 certified supplier with expertise in molding engineering grade thermoplastic and elastomeric materials, micro molding, and liquid silicone injection molding. Our diverse list of capabilities includes: complete design and engineering services, a dedicated R&D and rapid prototyping department, in-house CAD/CAM based tooling design and fabrication, insert molding, overmolding, white room molding, Class 100,000 and 10,000 clean room assembly. In addition, we offer extensive contract manufacturing services that include: assembly, machining, welding, decorating, packaging, and sterilization management. Web: www.donatelle.net |
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EtQ Solutions EtQ Reliance for Medical Device is an integrated quality and FDA compliance management system that has been pre-configured to specifically address the needs of the Medical Device industry. EtQ’s modules are tightly integrated to deliver a best-in-class FDA compliance solution. Modules include CAPA, Complaint Handling, Risk Assessment, Change Management, Nonconforming Materials, Document Control, and more. Web: www.etq.com/medicaldevice/ |
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Fischer Connectors For 50+ years, Fischer Connectors has designed, manufactured, and distributed high performance push-pull connector and cable assembly solutions. Offering highly flexible configurations, including low/high voltage, coax/ triax, fiber optic, liquid/gas and hybrid, our product range comprises over 10,000 items. Fischer products are ideal for medical electronic equipment such as diagnostic devices, surgical instrumentation, therapy applications, medical imaging, and cardiac assist devices. Web: www.fischerconnectors.com |
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FloMet, LLC FloMet LLC manufactures precision, high-volume metal components through metal injection molding (MIM). FloMet specializes in small, non-corrosive, dimensionally difficult parts with tolerance requirements of <1%. Stainlesssteel, cobalt and nickel based alloys provide strength/versatility. Custom tooling, sintering and heat treat furnaces, produce lowcarbon, high-density parts. ISO 9000-2000 certified. Web: www.flomet.com |
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Helix Medical Since 1984 Helix Medical has been a custom manufacturer for the medical device, health care, pharmaceutical, biotech, and IVD industries. Headquartered in Carpinteria, CA, Helix Medical operates an FDA-registered medical device facility, certified to ISO 13485 and ISO Class 7 & 8, with operations located in North America and Asia. Web: www.helixmed.com |
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Holmed Corporation Looking for reliability and quality? Looking for service you can count on? Then see Holmed Corporation for your next project needs. We specialize in orthopaedic products, especially for minimally invasive procedures. Make us your first and last stop. Web: www.holmed.net |
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Hoover Precision Products LLC Giving Form to Innovation. Hoover injection molds plastic medical components and precision ball products. Class 8 (ISO 1644-1) cleanroom with state of the art molding equipment, precision molds, rapid prototype/ SLA models, 3D modeling, vision inspection, custom build secondary equipment and value added operations. Contact our product development team today. Web: www.hooverprecision.com |
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Interface Interface Catheter Solutions is the only vertically integrated provider of outsourced solutions for catheter manufacturing. Interface has been solely focused on the balloon catheter market since 1995 and continually sets industry standards through process and equipment advancements in catheter manufacturing. Interface is ISO 13485:2003 and ISO 9001:2000 certified and operates multiple class 10,000 (ISO Class 7) and 100,000 (ISO Class 8) clean rooms in three facilities. Web: www.interfaceusa.com |
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Intermed OEM From design to production, Intermed OEM delivers high-quality products to the market faster and more economically. A single source contract manufacturer, we provide Industrial Design, Mold Design/Fabrication, Injection Molding, Machining, Assembly, Filling, and Packaging. With production facilities on both sides of the globe, we deliver affordable, high quality contract manufacturing; the “best of both worlds”. Dedicated teams on both sides of the ocean ensures your project receives the 24/7 management support you expect from an OEM partner. Certified ISO 13485:2003, CE, and FDA registered. Web: www.intermed-oem.com |
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Inzign Pte. Ltd. Inzign provides one-stop contract manufacturing solutions of plastic devices for the medical and health-care industry. Driven by passion and innovation, we have strong capabilities in product design & development; in-house tool design & fabrication. Staffed by a team of highly qualified human capital and equipped with class 10K/100K clean rooms for molding and assembly and process validation per cGMP, FDA 21 CFR part 820 guidelines and ISO 9001:2000 and ISO 13485:2003 certification, the company is well prime to support all manufacturing needs. Web: www.inzign.com |
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Kent Elastomer Products Kent Eastomer Products, Inc., announces the launch of a newly redesigned website that features easier accessibility to product types, data sheets and literature, and a user-friendly image gallery. Web: www.kentelastomer.com |
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Lyons Supplying RAPID Prototyping and production services to the medical device, instrumentation and implants industries. Proprietary tooling and processes and a “can do” approach have given Lyons a reputation as a leading provider of complete devices, welded and mechanical assemblies, CNC machined components, metal stampings, tubing and surgical scissors and sharps. Lyons, Medical Device Solutions, Meriden, CT. Web: www.lyons.com |
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MasterBond Adhesives/Sealants/Coatings Easy to navigate, informative web site describes Master Bond adhesive, sealant, coating, potting and encapsulation formulations. Line consists of epoxies, silicones, polyurethanes, cyanoacrylates and UV cures. Specific grades are available which are USP Class VI certified and resistant to repeated cycles of sterilization. We provide prompt technical assistance and solve problems. Web: www.masterbond.com |
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Medefab Medafab is a single-source, full-service, FDA-registered, ISO-certified medical product manufacturer. Complete in-house capabilities include tubing extrusion, insert and loose-piece molding, assembly, printing & decorating, hot stamp marking & other finishing operations. Disposable components and products are manufactured to the highest quality standard following strict production guidelines in order to meet the stringent demands of a broad range of medical specialties. Web: www.medefab.com |
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MediConcepts Limited MediConcepts Limited is a Hong Kong contract manufacturer of high quality medical devices. It provides complete manufacturing solutions with in-house design, prototyping, tooling, injection molding support and specializes in engineering thermoplastics, silicon, magnesium and Nitinol applications. It is ISO9001/ISO13485 certified with factory in China offering plastic injection molding, silicone injection molding, ultrasonic welding, assembly and packaging in cleanroom environment, mold making and fine metal machining, logistics and supply chain management. Web: www.mediconcepts.com.hk |
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Medtech Group, Inc. The MedTech Group is a leading global contract medical device manufacturer. As an ISO Certified 13485:2003 and FDA Registered Medical Device Manufacturer, The MedTech Group provides its customers with design through complete manufacturing services including, product design and development, tooling design and fabrication, process design and validation, surgical staple manufacturing, cleanroom molding including two-shot and insert molding, complete device assembly and packaging, sterility validation and management. Our website offers a password protected project center which gives our customers the opportunity for 24/7 access to updates on their project, instant meetings online and real time web meetings. Web: www.medtech-grp.com |
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Memry Corp. Celebrating over 25 years of providing innovative advanced material solutions to the medical device industry, Memry Corporation is a full service provider of Nitinol based technologies. The recent acquisition of Memry Corporation by the SAESGetters Group of companies will provide additional research and development resources required to assure that Memry remains a relevant innovative partner in the design and development of next-generation medical device products. Web: www.memry.com |
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Metal Craft & Riverside Machine & Engineering Metal Craft and Riverside Machine & Engineering are state-of-the-art contract manufacturers. They have served the medical device industry for over (25) years. Our services and capabilities include Prototype, Short and Long Run Production, Multi-axis (3,4,5) Milling, 7-10 axis Swiss Turning, 7-axis grinding, Laser Etching, Passivation and complex Assembly. Web: www.metal-craft.com |
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Micro Tube Fabricators, Inc. (MTF, Inc) Micro-Tube Fabricators is your premier source for precision fabricated metal tubular components for the medical industry. Our core competencies include machining, stamping, laser welding, sub-assembly and finishing. With our state of the art equipment and highly skilled technical staff, we are prepared to meet your most challenging and critical requirements. Web: www.hhmtf.com |
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MicroLumen Polyimide is ideal for critical applications and low-invasive medical devices. Typical applications include Cardiovascular & Urological catheters, Stent deployment and drug delivery systems. Polyimide has excellent mechanical, thermal & chemical properties. Braid reinforced designs available for added flexibility, torque & column strength. Thermoplastic jackets, multidurometer designs, flexible tips, contract sub-assembly, Ultra-thin PTFE liners & laser machining available. ISO 9001-2000. Web: www.microlumen.com |
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Minnesota Rubber & Plastics Minnesota Rubber and Plastics is a custom medical molder of rubber and plastic components including assemblies. Specializing in high performance materials we offer a complete solutions approach with services including product development, tool design and fabrication, prototyping, insert molding, silicone over-molding, assembly, class 10,000 and 100,000 clean rooms / packaging.Global manufacturing in 9 facilities. ISO 13485 certified and FDA registered. FDA Class 1,2, and 3 products including CE Products. Web: www.mnrubber.com |
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Modified Polymer Components Your partner for component level engineering and manufacturing. Providing innovative solutions to difficult challenges in order to deliver the best-quality, stable manufacturing services. Experienced with PEBAX, PE, Ultem, PEEK, FEP, PFA, PTFE and any thermoplastic. Tipping, flaring, hole drilling, marker band placement, printing, electrode assembly, and component level assemblies. 20 years serving the Medical Device and Diagnostic industries. ISO 9001/13485 Certified. Web: www.modifiedpolymer.com |
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MRPC MRPC is a single-source provider of innovative medical device components and assemblies specializing in silicone molding, two-material molding and micromolding. With our four certified clean rooms, two Class 10,000 and two 100,000, MRPC is dedicated to providing the highest level of manufacturing services to its customers. Web: www.mrpcorp.com |
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NDH Medical, Inc. NDH Medical, Inc. is a contract manufacturer of single use medical devices. Specializing in custom extrusion, NDH provides single and multi-lumen tubing, co-extrusions, tapered tubing, and paratubing available in a wide range of medical grade thermoplastics. Wire and coil coating (continuous and discrete lengths), injection molding, insert molding, tip forming, hole punching, printing, and packaging services are also available, as is turnkey manufacturing and inventory management. In-house tooling design and fabrication is available to reduce project lead times. Volumes from research and development runs to large scale ongoing production runs can be easily accommodated. Web: www.ndhmedical.com |
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Omnica Corp. Comprehensive medical product design and engineering. Research and Development services. Design control compliance and regulatory documentation. Realistic CAD rendering and animations. Fully equipped CNC prototyping and modelmaking shops. All aspects of medical product development from concept through hand-off to production. Twenty eight full-time employees perform all principle services in-house. Web: www.omnica.com |
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OraTech OraTech offers vertical integration specializing in manufacturing and packaging that meets precise specifications in the Medical industry. OraTech offers multiple services including Injection Molding, Thermoforming, Packout/Fullfilment, Blow Fill and Seal, Formulation/Batching, Tube Filling, Medical Machining, OraTech’s turnkey programs combine your companies industry knowledge with our manufacturing expertise to significantly reduce the time-to-market and improve profitability. Web: www.Oratech.com |
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Phillips Plastics Skilled at designing for multiple molding processes, Phillips' designers bring the manufacturing perspective to the concept phase. Add to that 176,000 square feet of FDA registered facilities dedicated to high volume and clean room medical manufacturing including a pilot facility to support clinical builds and you have a total solutions partner. Web: www.phillipsmedicalmolding.com |
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Potomac Photonics Potomac Photonics (experts in miniaturization) provides contract-manufacturing services from prototype to production. A wide variety of materials can be processed, such as polymers, metals, ceramics and glass. Feature sizes less than two microns can be realized in most materials. Potomac Photonics is ISO 9001:2000 certified and can process prototypes within 48 hours. Web: www.potomac-laser.com |
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Proven Process Proven Process Medical Devices is an ISO 13485: 2003 certified and FDA registered full-service outsourcing partner that offers exceptional design, development, validation and contract manufacturing services exclusively for the medical device industry. Proven Process provides expertise in mechanical engineering, digital and analog electrical engineering, software engineering, and contract manufacturing to established and emerging companies marketing novel Class II and Class III therapeutic and diagnostic medical products. Web: www.provenprocess.com |
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Ranfac Corp Ranfac is recognized for its ability to collaborate with healthcare professionals in the development of instrumentation that provides solutions to new and emerging needs. As a single source organization, the scale and breadth of our operations have enabled us to respond to the needs of health care professionals and to the requirements of medical device companies. Web: www.ranfac.com |
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Rapidwerks, Inc. Rapidwerks Inc. U.L. 13485 Registered Firm is generating increased interest worldwide among designers, engineers and medical device OEM’s for its ability to fabricate components that are almost microscopic in size efficiently and economically. Though definitions of micromolding vary, most experts will agree with Rapidwerks Inc. President Scott Herbert the demand to “Get Small” is wide spread. Rapidwerks focus to get small reflects this. They include medical device manufacturers, cardio-vascular devices and components, Orthopedics, implantable, obsorbable and Pharmaceutical applications. Web: www.micromolding.com |
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Raven Biological Laboratories Raven Labs, a division of Mesa Laboratories, Inc, manufactures Biological Indicators for validating sterilization processes. ProSpore Ampoule, ProSpore2 and ProTest (SCBIs), ProPACT for the System 1®, spore strips, suspensions, specialty carriers and BIs, incubators, Chemical Indicators and Integrators and steam and EO BIER testing services comprise the most complete line of sterility assurance products/services available from a single manufacturer Web: www.ravenlabs.com |
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Saint-Gobain Performance Plastics For more than 40 years, Saint-Gobain Performance Plastics (SGPPL) has been a global leader in silicone and fluoropolymer molding, thermoplastic, silicone, and fluoropolymer extrusion, and custom fabrication for medical device OEMs. SGPPL is able to customize and invent processing techniques to meet the most demanding product needs. Web: www.medical.saint-gobain.com |
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Scientific Molding Corporation SMC Ltd. offers OEM’s product manufacturing services including design, prototyping, molded components, subassemblies, and finished devices. With a global presence in North America and Asia, SMC’s facilities offer ISO 13485 certified quality systems with Class 7, Class 8, and white room molding and assembly environments. Web: www.smcltd.com |
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Sil-Pro Whether you need a single cavity prototype mold or a multi cavity fully automated molded part, Sil-Pro strives to produce the highest quality molded silicone parts utilizing the most cost effective methods. Our engineering team welcomes the opportunity to work with our customers on design development and implementation. Web: www.sil-pro.com |
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Tech-Etch Tech-Etch produces EMI/RFI shielding products, flexible circuits, and precision parts, including parts from materials special to the medical industry such as tungsten, elgiloy, titanium, polyimide, nitinol and molybdenum. Forming, plating and heat treating offered in-house. Specialized techniques for photoetching polyimide provide rapid turnaround for flexible circuits for medical applications. Web: www.tech-etch.com |
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TechDevice TechDevice Corporation, a developer and manufacturer of medical balloons, catheters, coil/core guidewire components and finished devices, welcomes OEM’s to its new and improved Web site. This easyto- use site features updated specifications and supporting images of all of TechDevice’s products and services. Of special value is TDXPress, a newly developed line of stock balloons and coil components, available for immediate shipment. TechDevice is ISO 13485 certified and FDA registered. Web: www.techdevice.com |
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Tegra Medical Expert manufacturing of complex wire and tubular components and assemblies. Tegra is a leading supplier of precision grinding, laser processing, EDM, CNC machining and secondary operations with 140,000 sq. ft. of manufacturing. The GENESIS Tech Center provides comprehensive support for product developers to reduce time to market. ISO 13485:2003 and ISO 9001:2000 Certified. Call 508.541.4200. Web: www.tegramedical.com |
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