חדש

MDR Master ClassUpdates on latest developments in the EU

בהדרכת: Mr. Robert Van Boxtel, Mr. Vincent van der Meer
גרסה להדפסה

שתף קולגה:

Help us make this masterclass more effective – submit your cases and questions in advance! The success of the masterclass depends on it! After signing-up to the masterclass, send your cases and questions to gad@bakc.co.il

Due to the Covid-19 pandemic, the EU Commission has decreed that the date of application of the MDR was postponed with one...המשך קריאה

Help us make this masterclass more effective – submit your cases and questions in advance!
The success of the masterclass depends on it!
After signing-up to the masterclass, send your cases and questions to gad@bakc.co.il

Due to the Covid-19 pandemic, the EU Commission has decreed that the date of application of the MDR was postponed with one year till May 26, 2021.
In practice this means that the MDD and AIMDD remain valid for another year. However, the “soft transition period” after May 26, 2021 till May 26, 2024 is not extended.

So, do not sit back and relax! Work towards meeting MDR requirements.

סגור
תאריכים: 
  • 18/11/2024
  • 20/11/2024
  • 25/11/2024
  • 27/11/2024

מתעניינים? לחצו כאן

    מיקום הקורס: מועבר באמצעות Zoom
    משך הפעילות: 4 מפגשים 1.5 שעות כל מפגש
    שעות: 17:30 - 16:00
    נקודות זכות: 2
    שפת הקורס: English

    עלות הקורס המלאה: ₪2,300 + מע"מ
    יש לך מנוי? מגיעה לך הנחה נוספת!

    יש לך שאלה? יש לנו את כל התשובות

    מה תכני הקורס?

    During the masterclass, the participants can upfront ask specific questions. They will be integrated in the subjects as identified below.

    • Day 1: Update on latest news from Brussels (Update on NB designations, latest MDCG guidances, EU Dashboard on certification status, impact amendment MDR/IVDR – Eudamed – notification requirements, any other latest developments) – Specific questions from participants
    • Day 2: QMS and TD requirements: Article 10+Annex IX vs EN ISO 13485; Technical dossier requirements; Labeling and language requirements; Discussion on findings made during audit and TD review; Role PRRC. Specific questions from participants
    • Day 3: Clinical evaluation – CEP, CDP, CER – linkage to RM, SSCP
    • Day 4: PMS – PSUR and PMCF+PMCFER – linkage to Clinical and RM

    למי זה מתאים?

    Specifically PRRCS will benefit from the information provided
    This Master Class is not suitable for beginners, as it will not discuss the fundamentals of the MDR

    מי מעביר את הקורס?

    Robert Van Boxtel
    Robert van Boxtel has over 20 years of experience in
    קרא עוד
    Vincent van der Meer
    Studied life sciences (molecular biology) in Leiden, The Netherlands. Started
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    הוספת תגובה

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