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Webinars

  • 23 januari 2018

    MDR Classification and Conformity Assessment routes

    Het derde webinar in de "MDR expert sessions" gaat in op hoe classificatie en conformity assessment routes anders zijn in de MDR ten opzichte van de Medical Device Directive (MDD). 

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    February 15, 2018

    IVDR: Status & Highlights

    In this status update we talk a.o. about:

    • An overview of the differences between IVDD and  IVDR
    • The classification system of the IVDR
    • The conformity assessment IVD

     

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    April 26, 2018
    IEC 60079-0

    New Edition 7.0 of IEC 60079-0

    IEC 60079-0 contains the basic requirements for all electrical products that need to be certified for use in zone classified areas and is therefore mandatory.

     

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  • 23 oktober 2017

    MDR Status & Highlights

    In deze status update bespreken we onder andere:

    • Tijdlijnen voor de transitieperiode
    • Impact op CE certificaten
    • Geldigheid van MDD en AIMDD certificaten
    • Transitie voorwaarden

    Bekijk dit webinar

    November 30, 2017

    New edition 7.0 of IEC 60079-0

    In this status update we talk a.o. about:

    • Preview into first changes of new standard
    • How you can start preparing

     

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    19 december 2017

    MDR Clinical Evaluation Requirements

    DEKRA's experts bespreken onder andere: 

    • Klinische evaluatie
    • Post market surveillance en klinische follow-up
    • CE keurmerk verkregen door gelijkwaardigheid

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  • October 25, 2016

    How the introduction of the new MDR and IVDR will impact you

    In this status update we talk a.o. about:

    • How can you prepare for the changes?
    • How will they impact your organization?
    • What are the most important highlights?

     

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    December 6, 2016

    Webinar upcoming change: transition to MDSAP

    In this status update we talk a.o. about:

    • How can you prepare for the changes?
    • How will they impact your organization?
    • What should I do to become MDSAP certified?

     

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    September 12, 2017

    Unlocking opportunities in the GCC markets

    In this status update we talk a.o. about:

    • Gulf Cooperation Countries in the GCC markets
    • Scope and upcoming changes
    • Technical documentation requirements
    • Registration system GSO

    Watch this webinar (English) Watch this webinar (Chinese)

  • April 7, 2016

    New EMC Directive 2014/30/EU

    In this status update we talk a.o. about:

    • Changes from the previous directive
    • The role of NBs and economic operators
    • Requirements on marking and technical documentation
    • Updates on harmonized standards

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    May 31, 2016

    ISO 13485:2016

    In this status update we talk a.o. about:

    • How the transition will impact you
    • In combination with transition ISO 9001:2008 to ISO 9001:2015

     

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    June 2, 2016

    IEC 62368: the new safety standard

    In this status update we talk a.o. about:

    • The basics
    • The objectives
    • Products covered by the standard
    • Practical information

    Watch this webinar