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• Packaging & Sterilization
  

  Package Testing and Validation: Interplay Between ISO 11607 Updates and MDR

  With recent updates to ISO 11607, Part 1 and Part 2, and the Medical Device Regulation (MDR) on track to replace Europe’s current Medical Device Directive (MDD) in 2020, medical device manufacturers are working hard to ensure their package desi…

  Britt Jones, Manager of Package Testing Services, WuXi AppTec 06.13.19
  

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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
  

  The Value of (Outside) Evaluation: Outsourcing Testing Services

  Testing service and equipment providers are challenged to stay abreast of regulatory guidelines.

  Sam Brusco, Associate Editor 03.15.18
  

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• Diagnostics
  

  FDA Clears Roche's cobas m 511 Analyzer for Hematology Testing

  Clinicians to benefit from integrated workflow and faster access to abnormal results.

  PR Newswire 03.09.18
  

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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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• 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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• 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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• Materials | Testing

  Laboratory Testing Inc. Adds New Business Development Sales Manager

  Bill DeHaven of Sellersville, Pa., has joined Laboratory Testing Inc. (LTI) as its new business development sales manager. In this position, DeHaven will be responsible for creating new business opportunities and growing LTI’s customer base. D…

  06.10.14
  

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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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• Contract Manufacturing | R&D & Design | Software & IT | Testing

  Validating Medical Device Software Includes and Goes Beyond Testing

  Validating Medical Device Software Includes and Goes Beyond Testing David A. Vogel, PhD, is president of Intertech Engineering Associates, Inc. in Norwood, Massachusetts. Intertech is an outsourced engineering service provider to…

  David Vogel 02.27.06
  

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