חדש

MDR MasterclassDetailed training on MDR subjects

בהדרכת: Mr. Robert Van Boxtel
גרסה להדפסה

שתף קולגה:

מקוון - בזום

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.

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: 
  • 13/01/2021
  • 20/01/2021
  • 27/01/2021
  • 03/02/2021
מיקום הקורס: הקורס יועבר באמצעות Zoom
משך הפעילות: 4 חצאי יום לימוד (ערב)
שעות: 18:30 - 17:00
נקודות זכות:
שפת הקורס: English

עלות הקורס: ₪1,800 + מע"מ
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מה תכני הקורס?

In two 4 hour session online, Mr. Robert van Boxtel will update you on the latest information regarding the MDR and MDCG publications relevant for manufacturers:

Impact of Covid-19 on implementation MDR – what happened in the EU.

Guidances on clinical evaluation:

  • MDCG 2020-5: Guidance on clinical evaluation – Equivalence
  • MDCG 2020-6: Guidance on sufficient clinical evidence for legacy devices
  • MDCG 2020-7: Guidance on PMCF plan template
  • MDCG 2020-8: Guidance on PMCF Evaluation report template

Guidances for Notified Body (with relevant information for manufacturers):

  • MDCG 2020-13: Guidance on Clinical Evaluation Assessment report
  • MDCG 2020-12: Guidance on consultation procedures (DD combination and TSE susceptible animal tissues)
  • MDCG 2020-14: Guidance for notified bodies on the use of MDSAP audit reports

EUDAMED:

  • MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States

Implementing acts

  • COMMISSION IMPLEMENTING REGULATION (EU) 2020/1207: Common Specifications for the reprocessing of single-use devices

MDCG work in progress – ongoing action plan.

Absence of Harmonized standards – impact for manufacturers.

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
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