חדש

MDR Master Class Overcoming the Challenges Behind Implementing
The New Regulation

בהדרכת: Mr. Robert Van Boxtel
גרסה להדפסה

שתף קולגה:

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.

המשך קריאה

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: 
  • 23/06/2021
  • 24/06/2021
  • 30/06/2021
  • 01/07/2021
מיקום הקורס: הקורס יועבר באמצעות Zoom
משך הפעילות: 4 מפגשים 1.5 שעות כל מפגש
שעות: 18:30 - 17:00
נקודות זכות:
שפת הקורס: English

עלות הקורס המלאה: ₪1,800 + מע"מ
ההרשמה המוזלת נסגרה
יש לך מנוי? מגיעה לך הנחה נוספת!

יש לך שאלה? יש לנו את כל התשובות

מה תכני הקורס?

  • Day 1: Update on latest news from Brussels (Commission MDR Rolling plan status, Update on NB designations, Status of MDCG guidance development, Discussion on content of some latest MDCG guidances)
  • Day 2: QMS and TD requirements: Article 10+Annex IX vs EN ISO 13485; Technical dossier requirements; Discussion on findings made during audit and TD review.
  • Day 3: Eudamed – Available modules – live demonstration of Eudamed through playground environment. If time allows – latest in UDI.
  • Day 4: Clinical evaluation, PMS and PMCF

למי זה מתאים?

This course will be extremely useful for the persons working in regulatory and quality assurance departments, and equally important for project managers or CTO’s involved in development of new medical devices. Last but not least, as CEO of a medical device company, you will obtain a clear insight in the new EU requirements and the impact it will have on your business case or company.

מי מעביר את הקורס?

Robert Van Boxtel
Robert van Boxtel has over 20 years of experience in
קרא עוד

2 תגובות ל- "MDR Master Class"

הוספת תגובה

    אנא חזרו אלי