Category: Device

  • Design Control for Medical Device Manufacturers

    Design Control for Medical Device Manufacturers

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    Lori
    in

    The FDA Center for Devices and Radiological Health (CDRH) March 11, 1997 issued the Guidance “Design Control Guidance for Medical Device Manufacturers“. This guidance is key to understand and implement today.

  • International Medical Device Regulators Forum (IMDF)

    International Medical Device Regulators Forum (IMDF)

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    by

    Lori
    in

    The purpose of the International Medical Device Regulators Forum (IMDF) is to develop global regulatory device best practices. IMDF working groups post a technical document called “Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (nIVD ToC).”  This useful global template compares common elements and denotes regional differences.  When submitting 510(k) and PMAs to the…