Product Spotlights
mdi Consultants Inc.
Web: http://www.mdiconsultants.com
Booth 2533
mdi Consultants, Inc. is a management consulting company specializing in FDA regulatory affairs, quality systems compliance and FDA strategic planning and troubleshooting. 510(k)/PMA preparations and submissions, clinical trials, setting up quality systems for FDA compliance, performing mock FDA audits, be present during FDA audits, assist in the responds to the FDA 483s and warning letters, in-house and on-demand FDA training programs, software and process validations. ISO13485 certification assistance, CE mark Technical File preparation for EU and Health Canada. Assist with Device Master Files for both the FDA and Canada. For foreign companies act as a US Agent and Official Correspondent.
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 MedPlast Inc.
Web: http://www.medplastgroup.com
Booth 1749
MedPlast Inc. is one of the nation's premier sources of precision custom-molded components for use in a broad spectrum of the heathcare market where technology, precision, skills in elastomers, silicone and plastics are vital. MedPlast is experienced in fully-integrated design, prototyping, engineering, tool-making, and production of components manufactured through multiple molding technologies. This one-stop, full-service capability is an asset to the designers of medical and surgical devices, who are under constant pressure to bring new products to market faster on a cost-effective basis, while meeting increasingly stringent quality assurance and compliance requirements. MedPlast Inc.'s facilities include over 375,000 square feet of manufacturing space in Arizona, Iowa, Wisconsin, Pennsylvania, and New Jersey.
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 Momentive Performance Materials
Web: http://www.momentive.com
Booth 2305
LSR7000 platinum-catalyzed liquid silicone rubber (LSR) series offers high optical transparency and excellent physical stability make it an ideal product to consider for healthcare, in applications such as wound drains, endoscopic devices, catheters, and respiratory components. Also, due to the excellent high temperature stability of silicone elastomers, the LSR 7000 series may be considered for applications in which potential stress cracking of thermoplastics is of concern.
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New England Urethane Inc.
Web: http://www.neuinc.com
Booth 1361
NEU (New England Urethane) has introduced a new, proprietary, non-plasticized Neusoft® urethane blends for a diverse range of 50-70 Shore A soft feel and touch medical, consumer and industrial applications including those requiring films. The new Neusoft® urethane blends can be injection molded, extruded or blow molded. Benefits include the properties of soft rubber and pricing comparable to polymers and thermosets which it is designed to replace.
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 NiCoForm Inc.
Web: http://www.nicoform.com
Booth 1948
Net Shape Electroforming is a process where a metal component is 'grown' from a solution of metal salts deposited on to a master model (mandrel), followed by separating the mandrel from the newly formed component. Involving little or no post-machining, this approach drastically reduces the amount of labor and materials required to fabricate a part, saving time and resources while assuring precision components and part-to-part consistency.
Suitable for cost-effective prototyping and mass production of precision high strength static and dynamic components, this technology is used by NiCoForm to manufacture parts and assemblies for medical, aerospace, motion control and optical applications, such as: miniature housings; stress-free bellows; catheter tip-forming dies; micro- and nano-fluidic molds; mirrors.
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 Norman Noble Inc.
Web: http://www.nnoble.com
Booth 1801
Norman Noble, Inc. is your single source for microprecision contract manufacturing of medical devices and implants. Our experienced engineers and technicians develop manufacturing processes for the most challenging of projects. We have the capacity (including over 120 proprietary laser machines) to take your project from prototype to full market requirements. Full capabilities include: proprietary Laser Micromachining, Laser Welding, Swiss Machining, Wire EDM, High-Speed 7-axis contour milling, Shape-Setting of Nitinol, Electropolishing, and additional Metal Finishing Processes. Prototype Services are available in our separate & fully dedicated departments. Registered to ISO 9001:2000 and ISO 13485:2003. Visit us at www.nnoble.com for more information.
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 Northeast Laser & Electropolish
Web: http://www.northeastlaser.com
Booth 1660
Northeast Laser & Electropolish is a one-stop source for laser marking, laser engraving, laser welding, laser cutting, electropolishing, and passivating services. The company specializes in corrosion-resistant laser marking, calibrated banding, deep engraving, mold engraving, linear and rotary laser welding, laser tube cutting, laser spot welding, electropolishing, and passivating of medical instruments and precision components.
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 Optical Research Associates
Web: http://www.opticalres.com/engr/engineering.html
Booth 861
ORAengineering will assist you in all phases of optical product development from concept validation through manufacturing. ORAengineering has successfully completed over 4,500 projects for biomed, government, commercial, and consumer products, including many breakthrough designs. As part of Optical Research Associates, the Engineering Services Group helps develop tomorrows cutting-edge optical design tools for imaging (CODE V) and illumination (LightTools). Using our extensive pool of manufacturing partners, we will tailor your design for the best manufacturable solution. For more information go to http://www.opticalres.com/engr/engineering.html To contact us try engr@opticalres.com, or call us at 626-795-9101 and ask for ORAengineering.
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 PAC Machinery Group
Web: http://www.pacmachinery.com
Booth 2326
Clamco's Magnum-MD Series exclusively for packaging medical supplies - with vital integrity and efficienty.
· Automatically forms and chevron-seals Tyvek®, polyester, polyethylene, metallized and other barrier films.
· Maximizes savings in material costs - utilizes tube stock, forms vast range of pouch sizes, allows virtually unlimited bag lengths.
Capabilities:
· Seals and perforates Tyvek®/polyester, and other barrier tubing films including HDPE, LDPE, LLDPE, polypropylene and nylon with a chevron seal.
· Utilizes tube stock, minimizing the possibility of contaminants entering bag that can occur when using pre-made bags on a roll.
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 Peter's Technology (Suzhou) Co., Ltd.
Web: http://www.peters.com.cn
Booth 1048
Peters contract manufactures and packages Final Medical Devices, Subassemblies, Cables and Wire harnesses in validated CER. US FDA Registered and ISO 13485 Certified. Capabilities include medical device assembly under microscope, hot box operations, ultrasonic welding, resistance welding, over-molding, injection molding, CNC machining, EDM Drilling, EDM wire cut, Laser welding, soldering, pad printing, UV bonding, etc. We want to be your one-stop solution for Final Medical Devices, Subassemblies, Cables, and Wire harnesses.
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 Porex Technologies
Web: http://www.porex.com/
Booth 2500
POREX diagnostic & medical materials and filters are fabricated from a wide array of polymer groups ranging in performance from PTFE to high density polyethylene. Designed to help deliver precision, accuracy and reliability, POREX diagnostic & medical materials and filters exemplify the critical design standards required in many challenging filtration, venting, wicking, diffusion and media support applications. New permanently hydrophilic materials manufactured without surfactants and with no chemical leachability will be on display.
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Profiles Inc.
Web: http://www.profiles-inc.com
Booth 2925
Profiles Inc. has a unique system for producing net and near-net components in medium to million-plus volumes, with extremely high repeatability and lead times that are significantly shorter than the industry norm. For customers with these requirements, the company provides a proven, high-precision, and low-cost alternative to machining, powdered metal, and EDM.
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 PTI Inspection Systems
Web: http://www.ptiusa.com
Booth 2425
PTI Inspection Systems manufactures nondestructive inspection technologies for the pharmaceutical, healthcare, and medical device industries. The company's technologies include VeriPac for package integrity testing using vacuum decay (ASTM method F2338-09, which is recognized by the FDA as a standard for package integrity testing), and Seal-Scan for pouch seal integrity and seal quality analysis using airborne ultrasound technology.
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 Qosina
Web: http://www.qosina.com/catalog/part.asp?partno=80129
Booth 2019
Qosinas pressure activated check valve (Part #80129) features a latex-free silicone diaphragm with flow direction from the female to the male luer lock.
The USP Class VI low priming valve generates a stable cracking pressure of 8-10 psi and is rated up to 330 psi. In addition, the polycarbonate body provides a clear view of the fluid path and this component is compatible with gamma or EtO sterilization.
Qosina offers an extensive inventory of syringes, luers, tubing, connectors, caps, tips, sheaths and other components to meet your medical needs.
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Quality Solutions Now
Web: http://www.qualitysolutionsnow.com
Booth 767
Project Management - planning and implementing change to produce results; Quality Systems Implementation & Compliance - establishing required systems and controls used for the manufacture of products intended for human use; Process Improvement - utilizing systematic methods to attain new levels of superior performance; Product & Process Development - promoting safety and efficacy of products manufactured for public use.
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 RepExact LLC
Web: http://www.repexact.com
Booth 2743
RepExact is pleased to announce North American representation of Tectri SA of Court, Switzerland.
Tectris key strength is the ability to perform complex turning, milling and small-diameter boring to single-digit micron tolerances and final finish levels on one machine, eliminating the need for secondary operations. Tectri can handle a variety of challenging materials, from elastic plastics to hard to machine metals such as Biodur 108. Specialties include implantables for orthopedic and cardiovascular applications, as well as micro-motor gear housings, shafts, and flanges.
Tectri is equipped to handle rod from 0.12 to 2.5 diameter, as well as blanks to 9.8 cubed, with the majority of products being approximately matchbox-sized. Assembly is also offered.
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RTEmd
Web: http://www.rtemd.com
Booth 1981
RTEmd provides outsourced software development and testing for complex medical equipment. We develop and maintain software for in vitro diagnostics, diagnostic imaging, therapeutics, microbiology, nephrology and life science applications. We offer New Product Development delivering high-quality, FDA-compliant software for your new medical products; Sustaining Engineering to maintain and enhance your existing software and extend the value of your installed products; and Verification and Validation to speed FDA approvals, leveraging our expertise in FDA compliance and testing. Our 27 years of experience with major device manufacturers, ISO 9001:2000 certified quality system, commitment to disciplined project management and client-focused flexibility power our promise: we will never compromise your time-to-market.
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 Sanderson MacLeod
Web: http://www.sandersonmacleod.com
Booth 743
As a manufacturer specializing in twisted in wire brushes, Sanderson MacLeod offers domestically produced twisted in wire medical brushes at manufacturer direct prices. Sanderson MacLeod twisted in wire medical products include disposable and reusable cytology brushes, instrument cleaning brushes, inter-dental brushes, guide wires and medical stylets. All medical brush products are made of FDA approved medical materials and are thoroughly documented to ensure regulatory compliance. All Sanderson MacLeod medical brushes are produced in a modern 137,000 square foot facility in Palmer, Massachusetts. The company utilizes the latest brush making technology combined with proprietary manufacturing equipment to provide unparalleled efficiencies and industry leading medical brush production rates.
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 Sikora International Corp.
Web: http://www.sikora-usa.com
Booth 2033
Sikora International Corp. is presenting a variety of excellent measuring, controlling, and testing equipment. Products range from the X-RAY 2000, for reliable measurement of wall thickness, eccentricity, ovality, and diameter; to state-of-the-art diameter LASER 2000 series gauges that require no calibration. The X-RAY 2000 is unique for its innovative, non-contact measuring principle; it is capable of measuring and controlling up to three layers of differentiated product materials and detecting defects inside the tube or hose. The LASER 2000 series offers both dual- and triple-axis gauges. Combine these with our control systems to optimize your production line and reduce material costs.
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 Silcotech North America Inc.
Web: http://www.silcotech.com
Booth 1049
Silcotechs two-shot capability, silicone on plastic or silicone on silicone in a single manufacturing cycle, is unique technologically and economically and presents new design opportunities as well as reducing defects, scrap and labour.
The economic and production benefits of Silcotechs assembly of silicone and plastic, or silicone on silicone in a single manufacturing cycle are also considerable. As well as new design opportunities, Silcotechs two-shot molding and insert-overmolding reduces defects, scrap, work-in-process and the cost of labor depending on the complexity of the design.
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