New

MDR Master ClassOvercoming the Challenges Behind Implementing
The New Regulation

Conducted by: Mr. Robert Van Boxtel
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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...Continue reading

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.

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Dates: 
  • 23/06/2021
  • 24/06/2021
  • 30/06/2021
  • 01/07/2021
Course location: Zoom Course
Duration: 4 meetings 1.5 hour each
Hours: 17:00 - 18:30
Credits: 1
Course Language: English

Course price: ₪1,800 + VAT
Early registration is Closed
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Issues to be covered

  • 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

Who should attend

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.

About The Lecturer

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