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  • Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications

    12 - 13 October 2017

    Berlin, Germany

    Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications https://tess.elixir-europe.org/events/medical-devices-eu-directives-guidance-ce-marking-and-iso-standard-certifications Things are changing for Medical Devices and IVDs in the European Union (EU): new fundamental standards, new EU device regulations and BREXIT. What is now needed to enter or, more importantly, to maintain presence in this attractive marketplace for medical devices? Satisfying requirements harmonized across the 28 member states should be a straightforward process to get products approved for distribution in each country - but is it? This course identifies and explains the requirements – old and new – for medical devices, the steps to obtain entry into the marketplace (including setting up on-going procedures and relationships), the increasing importance of Clinical Evaluation and Post Market surveillance, Notified Bodies and Competent Authorities. The course also shares some lessons learned from the Course Director, who has over 25 years of experience with CE marking medical devices for distribution in the EU. 2017-10-12 09:00:00 UTC 2017-10-13 17:00:00 UTC The Center for Professional Innovation & Education The Berlin Hilton, Berlin, Germany The Berlin Hilton Berlin Germany [] info@cfpie.com The Center for Professional Innovation & Education Medical Device 20 workshops_and_courses first_come_first_served EU DirectivesGuidanceCE MarkingISO Standard
  • Beacon - 2018 AHM Workshop

    7 June 2018

    Berlin, Germany

    Elixir node event
    Beacon - 2018 AHM Workshop https://tess.elixir-europe.org/events/beacon-2018-ahm-workshop ELIXIR workshop "Beacon", Jun 7 2018 at the ELIXIR AHM 2018, Berlin, Germany 2018-06-07 09:00:00 UTC 2018-06-07 13:00:00 UTC ELIXIR Germany and Beacon community Hotel Berlin Berlin, 17, Lützowplatz, Berlin, Germany Hotel Berlin Berlin, 17, Lützowplatz Berlin Berlin Germany Genomics Hotel Berlin Berlin [] life scientistsResearchers 30 workshops_and_courses registration_of_interest genomicsdata managementeLearningEeLP
  • Implementation of Data Management Plans & Data Stewardship in practice

    11 September 2018

    Athens, Greece

    Elixir node event
    Implementation of Data Management Plans & Data Stewardship in practice https://tess.elixir-europe.org/events/implementation-of-data-management-plans-data-stewardship-in-practice ELIXIR workshop “Implementation of Data Management Plans & Data Stewardship in practice”, taking place on Sept 11, 2018 as part of the ECCB2018 in Athens, Greece. 2018-09-11 17:30:00 UTC 2018-09-11 19:00:00 UTC Hellenic Society for Computational Biology Stavros Niarchos Foundation Cultural Center, 364, Leoforos Andrea Siggrou, Athens, Greece Stavros Niarchos Foundation Cultural Center, 364, Leoforos Andrea Siggrou Athens Attica Greece Data management Data submission, annotation and curation Stavros Niarchos Foundation Cultural Center [] bioinformaticiansdata stewards 30 workshops_and_courses registration_of_interest data managementdata stewardshipeLearningEeLP
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