Showing items tagged as In Vitro Device Regulation

  • Mind the Gap! The 3 Biggest Gaps Faced When Implementing IVDR

    July 13, 2020 by Sue Spenser, Head of IVD and Principal Consultant, Qserve

    If you are preparing to implement IVDR, there are specific gaps that are easily missed. Ensure the intended purpose is clear, risk management issues have been addressed, and pay close attention to details.

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  • The Importance of Intended Purpose and State of the Art in Implementing EU’s IVDR

    January 23, 2020 by Sue Spencer, Head of IVD and Principal Consultant, QServe

    The European Union’s In Vitro Device Regulation (IVDR) is replacing the In Vitro Device Directive (IVDD) on May 20, 2022, and there’s not a moment to spare in preparing for the new regulation. An in vitro diagnostic (IVD) expert with QServe lays out the most important requirements of IVDR that IVD manufacturers will need to begin planning for to recertify their devices.

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