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• Biocompatibility & Testing
  

  Making the Grade: A Testing and Analysis Roundtable

  This roundtable discussion examines the technological and regulatory factors affecting the third-party testing and analysis services industry.

  Sam Brusco, Associate Editor 09.17.19
  

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• Biocompatibility & Testing
  

  Why Big Companies With Internal Labs Should Outsource Testing

  Most of us know when we’ve hit that line signaling we’ve left our cutting edge and officially spread ourselves too thin. Pushing to do and be more is often a half-step from maxing out and dropping all those balls we’re juggling.…

  Dawn A. Lissy, President & Founder, Empirical 03.29.19
  

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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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• Extremities | Large Joint
  

  Revised ASTM Standard Will Help Test, Improve Elbow Prostheses

  Guidance should bring testing of elbow in line with other large total joint techniques.

  PR Newswire 05.16.17
  

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• Biocompatibility & Testing
  

  Testing Your Patience

  Changing FDA guidance and new technologies make device testing a challenging proposition for medtech OEMs.

  Mark Crawford, Contributing Writer 03.22.17
  

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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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