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  • Interphex Stands Test of Time (and Economy)
    By Paul Thomas, Senior Editor Budzar offers custom-built heat transfer systems specific to pharma, whether temperature control modules, low temperature chillers, biowaste systems, process skid packages, or a portable vessel heating/cooling system. Each custom unit or system design includes approval
  • Medical Device Link .
    The requirements of the section on acceptance activities (subpart H) replace the components, finished device inspection, and quality assurance approval requirements of the 1978 GMP regulation. The use of the term acceptance activities instead of inspection and test provides manufacturers
  • ISA100.11a Multi-Vendor Industrial Wireless Products in Sction (.pdf)
    Within days of approval of the ISA100.11a standard by the ISA Standards and Practices Board, the ISA100 Wireless Compliance Institute installed a multi-vendor User Test of the technology at an Arkema plant in Crosby, Texas. This User Test demonstrates interoperability among multiple vendor devices
  • Medical Device Link .
    Third Wave pharmacogenetic test cleared by FDA The promise of mainstream personalized medicine moved one step closer to reality with FDA's approval of the Invader UGT1A1 molecular assay by Third Wave Technologies Inc. (Madison, WI) in August. It is the first pharmacogenetic test to be cleared
  • Medical Device Link .
    Test Technologies The rapidly changing nature of medical devices submitted for FDA approval will require more advanced testing
  • Medical Device Link .
    Medical Device & Diagnostic Industry The rapidly changing nature of medical devices submitted for FDA approval will require more advanced testing technologies, says Kent Vilendrer, president of EnduraTEC Systems Corp. (Minnetonka, MN). Vilendrer suggests that there are four underlying reasons
  • Medical Device Link .
    Managing premarket approval for IVDs Part 1: FDA s PMA and 510(k) processes For most IVD manufacturers, large or small, the mere suggestion that a newly developed product may require a premarket approval (PMA) application to obtain FDA market approval can cause a great deal of anxiety. Although
  • Medical Device Link .
    electromagnetic field immunity is a requirement for competent body approval or self-certification under the Medical Devices Directive. In most cases, the required test standard is IEC 61000-4-3, which is published in Europe as European Norm (EN) 61000-4-3. Although the test is not mandatory in the United States
  • Everything you need to know about safety testing and certification
    license manufacturers to put approval marks on qualifying products. To qualify, products must pass rigorous, carefully controlled testing that determines if they meet applicable standards. Much of the confusion about approval marks stems from not understanding the differences between testing labs
  • The Future of Barrier Packaging
    are already examining how to use barrier packaging to reduce stability testing overhead in two separate arenas: pre- and post-approval. In the pre-approval world, if barrier packaging can reduce the time to approval, it will benefit the company, either by accelerating stability testing or enhancing
  • Software Review: Rapid Prototypes for Speedy Race Cars
    cars are no different from many engineering endeavors in that designs often require several changes before approval. So our shop makes lots of prototypes to test on cars for form and fit. About five years ago, to speed the prototyping phase, we started using direct-digital-manufacturing (DDM
  • Medical Device Link .
    during expansion and compression. FDA requires some form of a hoop-force test prior to approval to ensure that the stent product provides enough outward force. If the product lacks force, the stent may slip within the vessel, provide a path for leakage, or collapse under the pressure of the vessel
  • Medical Device Link .
    . Medical device manufacturers know that mechanical testing is a critical step in both the product development program and the FDA approval process. The test program manager must ask the right questions to ensure that accelerated test protocols meet the company's and FDA's requirements. These questions

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