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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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• Diagnostics
  

  Painless Skin Patch Collects Fluid for Diagnostic Testing

  Skin patch contains tiny needles that painlessly collect interstitial fluid for on-patch diagnostic testing.

  American Chemical Society 06.06.19
  

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• Testing
  

  Laboratory Testing with Nelson Labs at BIOMEDevice Boston

  Dr. Matt Jorgensen discusses the company’s new analytical chemistry approaches and how it’s preparing for the EU’s MDR deadline.

  Videos Sean Fenske, Editor-in-Chief

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

  Transformative Testing: Addressing Patient Safety and Cybersecurity

  With changing regulatory landscapes and requirements, testing providers are being asked to do more in terms of ensuring the safety of medical devices.

  Mark Crawford, Contributing Writer 03.07.19
  

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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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• Packaging & Sterilization | Testing
  

  Five Aspects of the ISO 11737-1:2018 Updates You Need to Know

  What medical device manufacturers need to know about the recent changes to the ISO bioburden standard.

  Martell Winters, Director of Scientific Competency, and Wendy Wangsgard, Ph.D., Senior Scientist—Nelson Laboratories 07.23.18
  

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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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• 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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