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  • EU MDR Postponed – What We Know Now and What's Next
    Eu Mdr

    EU MDR Postponed – What We Know Now and What's Next

    on 9 December 2022 | By Jaishankar Kutty, Ph.D., RQM+ VP of Intelligence & Innovation

    Earlier today, in the EPSCO meeting, all EU member states unanimously agreed to the proposal recommendations listed below. Belgium asked for a detailed root cause analyses of why the MDR roll out finds itself where it is today. Malta has asked for one single date as opposed to a...

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  • Using Chemical Characterization to Achieve Biological Equivalence
    Mdr

    Using Chemical Characterization to Achieve Biological Equivalence

    on 10 March 2022 | By Jaishankar Kutty, Ph.D., RQM+ VP of Intelligence & Innovation

    In the EU, a device is considered to be equivalent if and only if it fulfills all the requirements of technical, clinical, and biological equivalence. Of these, biological equivalence tends to be the most nuanced and can be a confusing topic for medical device...

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