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  • Feature ArticlesFeature Articles

    Making the call to test in-house or outsource

    With dynamics across the medical device industry continuing to evolve, manufacturers should evaluate their current standing to ask themselves if they should perform in-house testing, outsource or a combination of both. This article discusses key considerations before making a final decision.   Introduction   Transitioning to the stringent requirements of the European Union Medical Devices Regulation ( EU MDR ) continues to pose significant hurdles for medical dev...
  • Feature ArticlesFeature Articles

    EU MDR’s proposed delay and ISO 10993-18 compliance

    This article discusses the latest update to ISO 10993-18 released in January 2020. The author identifies changes implemented by this update and explains how they intensify the identification standard for medical devices and create new challenges for those companies working to certify devices under the European Medical Devices Regulation ( EU MDR). 1 The author suggests that while regulatory professionals must understand this standard to ensure their submissions are ful...