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• Biocompatibility & Testing
  

  Testing in a Rapidly Changing World

  OEMs seek risk assessment of their devices while regulatory scrutiny focuses on data and new requirements.

  Mark Crawford, Contributing Writer 09.19.18
  

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• Biocompatibility & 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 03.22.17
  

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• Biocompatibility & Testing
  

  New FDA Guidance for 510(k) Submission of Orthopedic Medical Implants

  The document could have a significant impact on the testing regimen for implant device manufacturers.

  Martell Winters, Senior Scientist and Consulting Manager; Quinton Inglet, Section Leader, Bacterial Endotoxin Testing, Nelson Laboratories 11.22.16
  

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• Biocompatibility & Testing
  

  Pay Attention, This Will Be on the (Device) Test

  Advanced materials and manufacturing methods for orthopedic technologies challenge testing service providers to stay current.

  Sam Brusco, Associate Editor 09.20.16
  

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  A Faster Real-World Porous Package Testing Method

  A testing facility evaluates the pros and cons of the ASTM F2638 porous packaging test.

  Craig Fisch, Nelson Laboratories 05.27.15
  

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• Machining & Tooling
  

  Testing Times

  New FDA draft guidance could shape the direction in which orthopedic device design, manufacturing and testing go in the future.

  Ranica Arrowsmith, Associate Editor 02.18.14
  

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