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Analogic Corporation Analogic Corporation is a leading-edge developer, designer, and manufacturer of OEM and end-user medical instrument systems, subsystems and accessories – with 40 years' experience in the medical instrumentation field. Our OEMs have relied on our expertise for all facets of product development, ranging from initial designs and prototyping to validation, regulatory approval guidance, and turnkey manufacturing. Our expertise in signal acquisition, processing algorithms, user interfaces, and hardware design is second to none. Web: www.analogic.com |
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Aubrey Group, Inc. Aubrey Group, Inc. in Irvine, CA specializes in design and manufacture of electromechanical medical devices. Services include system and electronic engineering, software and mechanical engineering, V&V, compliance testing, prototypes and manufacturing. Specialties include RF generators, wireless, fluidics, implantables, blood separation and pumping. The company is FDA-registered and ISO 13485 certified. 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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Battelle Battelle Medical Device Solutions delivers a comprehensive set of R&D services, including applied research, device development, clinical research, and sustaining engineering, to solve complex challenges involving medical device, biotechnology, pharmaceutical firms and key government health agencies. Battelle oversees nearly $200 million annually in health and life sciences-related work contributing to advances in medical devices, cancer detection, clinical trials, and next-generation diagnostics and therapeutics. Web: www.battelle.org/medical |
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Carclo Technical Plastics Carclo Technical Plastics is the result of strategic acquisitions by Carclo PLC to form a world leading supplier of tech-nical solutions for global companies. The foresight of Carclo has bred an innovative company continuing to develop emerging tech-nologies in the areas of conductive ink applications, innovative surface coatings, and body soluble polymers used in conjunction with its injection molding and value added operations. Web: www.carclo-plc.com |
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Criterion Instrument Criterion Instrument, an FDA registered, ISO 9001:2000 certified precision machine shop that supports medical device companies by producing medical instruments, implants and diagnostic instrumentation. We manufacture prototype components for Class II & Class III medical devices. Visit Criterion’s website to view samples of our expertise in CNC Milling, Turning & Swiss Turning. Web: www.criteriontool.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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EPIC Technologies EPIC Technologies is a top 10 EMS provider of Medical devices globally. We specialize in providing comprehensive solutions, from design through post-manufacturing support. Our facilities are FDA registered and certified to ISO 9001:2000 and ISO 13485. Our key differentiator is our focus on lean manufacturing which provides our customers with faster response to schedule changes, minimized inventory liability and lower overall cost. Web: www.epictech.com |
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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, Compliant Handling, Risk Assessment, Nonconforming Materials, Document Control, and more. Web: www.etq.com/gmp |
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FloMet, LLC FloMet LLC is a metal injection technology company that specializes in custom manufacturing small, complex components in large volumes. Alloys consist of stainless steel, Kovar, F75 and more. FloMet's process is a viable, less expensive solution to machining and other processes. ISO 9001 and 9002 Certified. Web: www.flomet.com |
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Helix Medical Helix Medical, LLC is a developer, manufacturer and supplier of custom fabricated silicone components and products for the medical device industry world-wide. Our manufacturing capabilities include compression and transfer molding, state-of-the-art Liquid Injection Molding, extrusions, packaging, and assembly. Our platinum-cured silicone products are manufactured following Good Manufacturing Practices (GMP’s) in an FDA registered medical device facility that is certified to meet ISO 13485 Quality Standards. Helix Medical products meet USP Class VI biocompatibility requirements. Web: www.helixmed.com |
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Hi-Tech Group Consisting of HI-TECH RUBBER, A. C. HOFFMAN, INLAND TECHNOLOGIES, VENTREX, INFINITY and ACCUSIL, the HI-TECH GROUP is a single source contract manufacturer for molded plastic, silicone-rubber components, medical grade tubing and fabricated medical devices. The company offers in-house tooling, rapid prototyping and full scale production in ISO 13485 facilities with Class 10,000 and 100,000 clean-rooms. Web: www.hi-tech-group.com |
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IBS Simplify compliance with regulatory requirements and alleviate the burden of high audit costs. IBS software solutions help medical device manufacturers attain certification to ISO 13485 and 14971, prepare for FDA audits against 21 CFR 820, and simply streamline business processes for cGxP. Web: www.ibs-us.com |
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Instrumentation Industries iiiMedical OEM is a leader, innovator and manufacturer of low cost, high quality injection molded specialty medical components. We offer injection molded parts of thermoplastics engineering-grade resins, TPE, silicone rubber and the precision machining of metal and plastic. Capabilities include complete engineering and design services, tool &die building, rapid prototyping, precision machining, sonic welding, hot stamping and full assembly. ISO 13485:2003 certified, FDA registered and cGMP compliant. Web: www.iiioem.com |
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Integrated BioSciences, Inc. Products and equipment available are Class I and II medical devices and disposables and automated equipment. Complete contract manufacturing services for Class I and II medical devices are offered. Capability to design, fabricate and operate automated equipment used in the production of those devices. Web: www.ibiosci.com |
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Invetech Pty. Ltd. Invetech specializes in contract design, development and manufacture of instruments, disposables and automated systems for clinical diagnostics, life sciences, drug discovery and pharmaceutical companies. Our track record includes 60+ projects, with more than 6,000 instruments manufactured. Our in-house team of 150+ engineers, designers and scientists delivers high quality, fast-to-market results at competitive cost. Web: www.invetech.us |
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ITI / Instrument Technology, Inc. Instrument Technology, Inc. (ITI) is an ISO-compliant, FDA-registered manufacturer of endo-scopes, videoscopes, and other optical and mechanical devices. The ITI Medical division helps OEM customers at every stage from design and prototyping to long-term manufacturing of large production runs. Web: www.scopes.com |
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LaVezzi Precision Inc. LaVezzi Precision enhances the flexibility of today's machine tools even more with creative programmers and operators. They utilize the latest in multi-tasking equipment along with the auxiliary support required to meet the most demanding production specifications for accuracy, repeatability and rigidity. From micromachining to deburring, our equipment offers you virtually any precision machining operation for nearly every type of geometric specification and tight tolerance you require. Web: www.lavezzi.com |
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Lyons Since 1951 Lyons has provided precision manufacturing services. Our specialty is extremely rapid prototyping and production of metal stampings, surgical knives and scissors, CNC machined components, Wire EDM and assemblies. Class 10,000 clean rooms are available for assembly and packaging requirements. Program management, product development and design and build of progressive dies also provided. Pro/Engineer, SolidWorks and AutoCAD utilized. Web: www.lyons.com |
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MDSS MDSS specializes in European regulatory affairs. MDSS acts on behalf of its clients as “Authorized Representative” according to the European CE marking regulation IVDD 98/79/EC, MDD 93/42/EEC; and AIMDD 90/385/EEC. Certified to EN ISO 13485 – MDSS provides support and consultation in product registration, incident reporting, recall management, labeling, instructions for use and technical files etc. Web: www.mdss.com |
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Medical Device Consultants (MDCI) Medical Device Consultants, Inc. is a full-service CRO and regulatory consulting practice focused on the needs of emerging and established medical device and diagnostic manufacturers. MDCI has helped hundreds of clients conduct successful clinical trials, achieve regulatory clearance and approval, and maintain compliance for products in the U.S. and internationally. Web: www.mdci.com |
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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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MRPC MRPC is a single-source provider of innovative medical device components and assemblies. The company offers design engineering assistance and custom material development. Manufacturing capabilities include silicone molding, TPE molding, custom rubber molding, silicone extrusions, two-material molding, and laser machining. MRPC is ISO 9001:2000 certified with Class 100,000 and Class 10,000 clean room processing. Web: www.mrpcorp.com |
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National Cable Molding National Cable Molding is an ISO 9001 certified and FDA registered manufacturer specializing in molded cable assemblies for electro-medical equipment. We deliver 30+ years of material selection knowledge and technical manufacturing experience to meet the critical care needs of our clients. Web: www.nationalwire.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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Norman Noble, Inc. Norman Noble Inc. has contract manufacturing capabilities that meet the complexity of micromachining and include laser micromachining, laser welding, wire EDM, CNC Swiss machining, and shape setting of Nitinol. Prototype machining services ensure the accuracy of the final product. Laser, Swiss, and Wire EDM R&D departments are located near production, at one location. The company is registered to 9001:2000 and ISO 13485:2003. Web: www.nnoble.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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Phillips Plastics Skilled at designing for multiple molding processes, Phillips' designers bring the manufacturing per-spective to the concept phase. Add to that four FDA registered facilities with over 100,000 square feet dedicated to medical manufacturing 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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PPC While specializing in development projects, Putnam also offers a state-of-the-art manufacturing facility which naturally, has achieved ISO 9002 certification and reaffirms the company's goal of maintaining a quality system of the highest possible standards. Along with a full line of products, Putnam provides the latest in online statistical quality control. Further, a Class 100,000 cleanroom is ideal for implantable and thin-wall medical tubing. Web: www.putnamplastics.com |
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PPC Plus Our dedicated focus to providing Secondary Operation Solutions within Putnam Plastics Company, offers customers the added benefits of efficiency, traceability and consolidated resources. Eliminate the variables stopping you from getting your device to market faster. Choose a manufacturing partner who understands the value of a streamlined supply chain. Web: www.putnamplus.com |
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Scantibodies Laboratory, Inc. SCANTIBODIES Laboratory, Inc. Celebrating 30 years as a Manufacturer and Contract Manufacturing Partner for Quality Diagnostic Products. 30 years experience and an award-winning track record ensure our partner OEM companies: A trustworthy manufacturer, Product quality maintenance is job #1, Adequate production volumes maintained, even during transfer, On time shipping on correct shipping dates, Proper compliance demonstrated through inspections and audits, Experienced lead team and managers for good communication, Plenty of growing room in new, 125,000 sq. ft. Tecate, MX facility. You can rely on Scantibodies Laboratory for all your OEM needs! Web: www.scantibodies.com |
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Sparta Systems Sparta Systems is the maker of TrackWise®, the medical device industry’s standard for managing quality and regulatory compliance requirements and related actions. TrackWise helps medical device companies improve their CAPA and Complaint and Adverse Event Reporting systems by streamlining operations and reducing the costs associated with product design, manufacture, maintenance, and customer support. TrackWise software is a web-based, 100% configurable application that comes with pre-configured solutions base on best practices for the medical device industry. Web: www.sparta-systems.com |
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Specialized Medical Devices Implants – Instruments – Class 10,000 Clean Room Packaging. SMD specializes in complete spinal implant systems, small bone implant systems as well as custom orthopedic instrumentation. SMD is a full service manufacturer from prototype runs to full production. SMD’s expansive in-house capabilities include: Ultra precise CNC-Swiss screw machining, 5-axis vertical milling, wire EDM, titanium anodization, a validated implant cleaning process, heat treating, laser marking, anodizing, electropolishing and passivation. Materials: titanium, stainless steel, cobalt chrome and Peek. FDA registered, ISO 13485:2003 certified. Web: www.specializedmedical.com |
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Symmetry Medical Inc. Symmetry Medical (NYSE:SMA) is a leading provider of implants, instruments and cases to orthopedic device manufacturers. We also design, develop and produce these products for companies in the arthroscopy, dental, laparoscopy, osteobiologic, endoscopy and other segments of the medical device market, as well as provide specialized products and services to the aerospace market. Web: www.symmetrymedical.com |
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The Tech Group The Tech Group provides custom molding and contract manufacturing solutions for the medical device and pharmaceutical industries worldwide. With 14 facilities located throughout the United States, Mexico, Puerto Rico and Europe, we offer a variety of technologies including integrated work-cells, insert molding, multi-component molding, in-mold labeling, RFID capabilities and a variety of secondary operations. Core competencies include product & tool design, tool building, validation and turnkey assembly solutions. The Tech Group is a Class II and Class III medical devices manufacturer, and can assist with plant consolidations and transfer requirements Web: www.techgroup.com |
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Triangle Manufacturing Company Inc. Triangle is a leading manufacturer of surgical implants and medical instruments, with a special expertise in powered hand tools. Our Medical Manufacturing Group collaborates with our customers to develop the industry’s most advanced products for the orthopedic, ENT, cranial, trauma, rehabilitation and sports medicine markets. Web: www.trianglemfg.com |
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UFE Inc. UFE offers excellent capabilities throughout the development and production continuum – from product engineering/DFM/DFA, injection molding and mold manufacturing through contract assembly – to produce precision medical products cost-effectively with continuous, flawless quality. Seven plants in North America and Asia. Web: www.ufeinc.com |
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