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 MAY 2008 |
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| FEATURED EDITORIAL |
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Testing and Inspection Providers Attempt to Stay Fluid "We are seeing more drug-device combination products as well as more devices that interact with computers," says Jeff Nelson, president and CEO of Nelson Laboratories Inc. (Salt Lake City, UT), which provides microbiology testing services to the medical device industry including sterilization validation, routine lot-release testing, and biocompatibility testing. "These devices are highly specialized and we are having to tweak our processes on a case-by-case basis in order to accommodate them." Another trend necessitating new testing methodologies is the increasing number of patient-specific devices, Nelson says. In these cases, each unit has unique dimensions and contours. Such customization requires special care in devising procedures for sterilization and microbial testing. Read More |
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Leak-Testing Instruments
Cincinnati Test Systems Inc. is prominent in the design and manufacture of leak-testing and assembly-verification solutions for a wide range of manufacturing operations. The company specializes in leak-testing and signature analysis monitoring instrumentation for use in quality, performance, and functional testing and in assembly process verification. The Sentinel family of pressure-decay and mass-flow instruments for leak testing offers best-in-class performance and features and stands out in its market. CIncinnati Test Systems Inc. |
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Catheter and Stent Testing Offering contract testing services, Machine Solutions Inc. can quantitatively analyze catheter and stent trackability and pushability and measure and record radial stiffness, strength, and pressure during expansion and compression of such interventional devices as balloon-expandable and self-expanding stent and stent graft products, collagen plugs, embolic filters, vena cava filters, and other basket-type filter products. The company’s testing protocols are designed in collaboration with customers and reflect ASTM and ISO guidance documents and ASTM test methods. Machine Solutions Inc. |
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Laboratory Test Services
Nelson Laboratories Inc. is an independent test services provider specializing in microbiology; sterilization validation; lot release tests for sterility, bioburden, B/F, pyrogen, particulates, etc.; biocompatibility; organism identification; residuals; filter validations; and much more. A 62,000-sq-ft facility contains 80 specialty laboratories and a custom-built state-of-the-art 3,000-sq-ft sterility testing cleanroom suite. The company employs more than 300 staff members, including more than 120 degreed scientists among whom are 50-plus NRM-registered and specialist microbiologists. Nelson Laboratories, Inc. |
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Package Testing Equipment
Simple-to-use package testing equipment from Test-A-Pack Systems, Carleton Technologies, is based on advanced technology. Minutes out of the box, fully ASTM-compliant systems can be testing accurately and repeatably at the press of a button. They seamlessly adapt to test requirements for different types of packages, being designed to eliminate the trial and error associated with continual adjustments of settings. No tweaking is necessary. The manufacturer offers systems for package seal-strength, integrity, and leak testing.Test-a-Pack Systems, Carleton Technologies |
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Notified Body Services
TÜV SÜD America Inc. is a European Union notified body for the In Vitro Diagnostic, Medical Devices, and Active Implantable Medical Devices directives. The service provider offers ISO 9001 and ISO 13485 certification, SCC ISO 13485 registration to the Canadian Medical Devices Regulations, FDA 510(k) reviews and third-party inspections, NRTL and product safety certification, and electromagnetic compatibility (EMC) and environmental testing. TÜV SÜD America |
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PRODUCTS AND SERVICES |
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Leak Testing System Guidewire Gauging System Label Inspection System |
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