Wade Munsch

Wade is the Director of Regulatory Affairs for Biotex, Inc. and the Laboratory Manager for Criterion, a Biotex, Inc. service. He has worked in compliance for over 14 years, including standards development and electrical safety evaluations with a specialty in medical devices. Throughout his career, Wade has worked for Certification Body (CB) and Nationally Recognized Testing Laboratory (NRTL) test laboratories and medical device manufacturers.
/ Regulatory /

The FDA Breakthrough Device Program: Accelerating Innovative Medical Devices to Market

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Wade Munsch
Director of Regulatory Affairs for Biotex and Laboratory Manager for Criterion

    The development and approval of new medical devices can often take many years and require extensive clinical trials and regulatory review before they can be marketed to the public.

    ABOUT THE AUTHOR

    Avatar photo
    Wade Munsch
    Wade is the Director of Regulatory Affairs for Biotex, Inc. and the Laboratory Manager for Criterion, a Biotex, Inc. service. He has worked in compliance for over 14 years, including standards development and electrical safety evaluations with a specialty in medical devices. Throughout his career, Wade has worked for Certification Body (CB) and Nationally Recognized Testing Laboratory (NRTL) test laboratories and medical device manufacturers.
    / Regulatory /

    What You Need to Know About Medical Production Line Testing

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    Wade Munsch
    Director of Regulatory Affairs for Biotex and Laboratory Manager for Criterion
      What You Need to Know About Medical Production Line Testing

      As a Regulatory Specialist with more than ten years of experience in conducting safety testing, let me shed light on medical production line testing to help you understand the process…

      ABOUT THE AUTHOR

      Avatar photo
      Wade Munsch
      Wade is the Director of Regulatory Affairs for Biotex, Inc. and the Laboratory Manager for Criterion, a Biotex, Inc. service. He has worked in compliance for over 14 years, including standards development and electrical safety evaluations with a specialty in medical devices. Throughout his career, Wade has worked for Certification Body (CB) and Nationally Recognized Testing Laboratory (NRTL) test laboratories and medical device manufacturers.
      / Regulatory /

      4 Reasons Your Medical Device Needs an Expert Testing Lab Now

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      Wade Munsch
      Director of Regulatory Affairs for Biotex and Laboratory Manager for Criterion
        4 Reasons Your Medical Device Needs an Expert Testing Lab Now

        After countless hours on the drawing board and verifying that every aspect of your medical device is ready to be tested, you’re all fired up. The medical device you’re developing is the next big thing, ready to save lives and rock the world like never before. However, it must pass compliance and regulatory standards to … 4 Reasons Your Medical Device Needs an Expert Testing Lab Now

        ABOUT THE AUTHOR

        Avatar photo
        Wade Munsch
        Wade is the Director of Regulatory Affairs for Biotex, Inc. and the Laboratory Manager for Criterion, a Biotex, Inc. service. He has worked in compliance for over 14 years, including standards development and electrical safety evaluations with a specialty in medical devices. Throughout his career, Wade has worked for Certification Body (CB) and Nationally Recognized Testing Laboratory (NRTL) test laboratories and medical device manufacturers.