Search Results for 'testing'

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• Diagnostics
  

  FDA Clears Hycor Biomedical's NOVEOS Modern Allergy Testing Instrument

  NOVEOS employs microparticles, chemiluminescence, and liquid ready-to-use reagent.

  PR Newswire 12.19.18
  

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• Cardiovascular | Neurological | Surgical | Testing
  

  Active Implantable Medical Device Testing: What You Need to Know

  Both the implanted product and non-implantable supporting equipment require testing and evaluation to specific standards.

  Online Exclusives William Stearns, Associate Senior Engineer, Intertek 08.13.18
  

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• Testing
  

  FDA's Expansion of 510(k) Program Seeks to End Predicate Testing for Some Devices

  Voluntary, modern 510(k) pathway may enable moderate risk devices to more efficiently demonstrate safety and effectiveness.

  U.S. Food and Drug Administration 04.13.18
  

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• Digital Health | Electronics | Software & IT | Testing
  

  Coexistence Testing for Wireless Medical Devices: A Guide to Ensuring Reliable Systems

  With mobile medtech in healthcare facilities and the home, OEMs must ensure interference is not a cause for concern.

  Online Exclusives Ashton Hainge, Consultant, Intertek 08.02.17
  

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• Testing
  

  Extractable/Leachable Chemistry Testing Strategies for Medical Devices

  It has become more prevalent and acceptable to use the results of chemistry testing to assess the overall biocompatibility of medical devices. For many devices with prolonged or permanent patient contact, chemistry followed by toxicological assessmen…

  Matthew R Jorgensen, Ph.D., and Thor Rollins, BS, Nelson Laboratories; Allison Komiyama, Ph.D., RAC, AcKnowledge RS 04.03.17
  

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• Testing
  

  Testing…Testing…Is This Thing On? Should You Outsource Device Testing or Keep it In-House?

  When people ask me what I do, I often reply, “I break things for a living.” Yes, I say it with tongue firmly in cheek. That’s a gross oversimplification of a business I’ve been in for almost 20 years: mechanical testing for…

  Dawn A. Lissy, President & Founder, Empirical 03.07.17
  

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• R&D & Design | Testing
  

  5 Considerations for Human Factors Testing

  When developing a device, the way it will be used, who uses it, and where it’s used are all critical factors to consider.

  Online Exclusives Kady Harper, Technical Writer 09.13.16
  

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• Cardiovascular | Contract Manufacturing | Materials | R&D & Design | Testing | Tubing & Extrusion
  

  Constantly Tested

  Testing providers need to stay ahead of regulatory, material and manufacturing trends to consistently meet the needs of medical device firms.

  Mark Crawford, Contributing Writer 03.11.15
  

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• Packaging & Sterilization | Testing
  

  Functionality vs. Simulated-Use Testing in Device Reprocessing

  A brief look at functionality vs. simulated-use testing for processing and reprocessing of reusable scopes and medical devices.

  Online Exclusives Emily Mitzel, Alpa Patel & Nick Workman, Nelson Laboratories, Contributing Columnists 09.11.14
  

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• Contract Manufacturing | Materials | R&D & Design | Testing | Tubing & Extrusion
  

  Testing the Medical Device Testers

  A host of new and upcoming compliance requirements not only pose a challenge for medical device makers, but to their contract testing partners as well.

  Mark Crawford, Contributing Writer 03.13.14
  

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