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      26Jul
      Thoracolumbosacral Pedicle Screw System Performance Data from the FDA
      By Brian Buckin FDA

      Thoracolumbosacral Pedicle Screw System Performance Data from the FDA

      In a recent article presented in the Journal of Biomechanics, “Mechanical performance of thoracolumbosacral pedicle screw systems: An analysis of data submitted to the Food and Drug Administration,” members of…

      16Oct
      Biocompatibility Pulse Check: How FDA’s New Requirements Affect Our Industry
      By adminin FDA, Medical, Product Development

      Biocompatibility Pulse Check: How FDA’s New Requirements Affect Our Industry

      We all knew it was coming—new regulations regarding biologics. The U.S. Food and Drug Administration (FDA) issued guidance in 2016 for ISO 10993-1, partially in response to a number of…

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      With over 20 years of trusted experience, Empirical is your expert partner for mechanical testing, regulatory consulting, and prototyping providing comprehensive & proven solutions. We specialize in the testing of medical devices. ISO/IEC 17025:2017 Accredited.

       

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      Thoracolumbosacral Pedicle Screw System Performance Data from the FDA
      July 26, 2021 by Brian Buck
      Thoracolumbosacral Pedicle Screw System Performance Data from the FDA

      In a recent article presented in the Journal of Biomechanics,…

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