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Tagungsberichte - VDGH - Verband der Diagnostica-Industrie e.V.www.vdgh.de › tagungsberichte › ivd-informationsse...

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Petra Kaars-Wiele (Abbott) erläuterte den neuen Verordnungsbegriff „Klinischer Nachweis“ und zeigte Quellen zum Nachweis der wissenschaftlichen Bewertung auf.

PLANNING THE ACTIVITIES Laurent Sellès DHoU SANCO B2slideplayer.com › slide

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SG1 Subgroup IVD Marie-Lise Migueres (FR) C é line Bourguignon (COM) Benny Ons (EDMA) Michael Thein (EDMA) Petra Kaars Wiele (EDMA) SG2 Post market ...

GLOBAL HARMONIZATION TASK FORCE (GHTF) UPDATE: PLANNING THE

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SG1 Subgroup IVD Marie-Lise Migueres (FR) C é line Bourguignon (COM) Benny Ons (EDMA) Michael Thein (EDMA) Petra Kaars Wiele (EDMA) SG2 Post ...

Understanding the IN VITRO DIAGNOSTIC REGULATION (IVDR) Everything...

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Dr. Petra Kaars-Wiele. Independent Consultant, Chairwoman of the MedTech Europe Globalization Working Party, IVD Advisor to AHWP TC Biography. Petra graduated from the University of Goettingen/ Germany with Diploma in and with Ph.D. in She joined Abbott Laboratories in the same year where she assumed increasing leadership responsibilities in the Regulatory …

helsingin MESSUKESKUs - PDF Ilmainen lataus

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25 International Program, Friday Hall 203 Chairs Solveig Linko and Harri Laitinen IVD Regulations AND QUALITY SYSTEMS 10:00 10:30 am New requirements authorities view M.D. Ph.D. Kimmo Linnavuori, National Supervisory Authority for Welfare and Health, Finland 10:30 11:00 am The new IVD regulation and the challenges for the industry Ph.D. Petra Kaars-Wiele, Abbott, Germany …

EU MDR & IVDR: THE RACE IS ON PDF Free Download

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... Compliance (PRRC) under the IVDR from a practical standpoint Petra Kaars-Wiele, Senior Director International Regulatory Affairs & Global Labeling, Abbott, ...

Mdr Ivdr Sufficient Clinical Data Equivalency For Legacy Devices ...admision2.unap.edu.pe › sugihbareng › mdr.ivdr.sufficient.clinical.data.eq...

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Presented By: Dr. Petra Kaars-Wiele Speaker Biography: Petra graduated from the University of Goettingen/ Germany with Diploma in and with.

Oman Virtual Training (30 Nov – 3 Dec 2020) | AHWPwww.ahwp.info › index.php › node

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Dec 8, · It is our honour to have Ms. Joanna Wee and Dr. Petra Kaars-Wiele as speakers to provide participants insights on IVD, EU regulation and ...

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Petra Kaars-Wiele and Ivd Free People Check