EU MDR Clinical Public Training with Dr. Bassil Akra 13.10.2020

Date: 13.10.2020
Time: 9:00 AM to 6:00 PM (Eastern Time Zone GMT -4)

(To calculate the correct time zone, please feel free to use the button “Time zone converter” and use Berlin as a reference European Time)

Duration: 9 hours
Location: Virtual Training
Language: English
Fee: 699 €

Description:

The EU MDR 2017/745 introduced higher clinical requirements for new and legacy devices which are targeting a certification under this regulation. To ensure fulfilling the requirements of this regulation and make use of the interpretation of the various new guidance documents accordingly, we are offering detailed insights about the requirements, their background and the best way to show compliance. Don´t miss this event and learn more from our valued experts.

Topics:

  • Clinical evaluation requirements under the MDR
  • Usage of MEDDEV 2.7/1 Rev. 4 to fulfill the MDR requirements
  • MDCG 2020-1 Guidance on clinical evaluation of medical device software
  • MDCG 2020-5 Guidance on clinical evaluation Equivalence
  • MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices
  • MDCG 2019-3 rev. 1 Interpretation of article 54(2)b
  • MDCG 2020-7 Guidance on PMCF plan template
  • MDCG 2020-8 Guidance on PMCF evaluation report template
  • MDCG 2019-8 V2 Guidance document implant card on the application of Article 18

Schedule:

  • 09:00 – 11:00 Presentation
  • 11:00 – 11:15 Coffee Break
  • 11:15 – 13:30 Presentation
  • 13:30 – 14:15 Lunch Break
  • 14:15 – 16:00 Presentation
  • 16:00 – 16:15 Coffee Break
  • 16:15 – 17:30 Presentation
  • 17:30 – 18:00 Q&A session

In order to keep the training interactive, the exact content schedule cannot be provided.

Certification:

Personal Certificate

Presentation:

Presentation will be provided in PDF

Book now:

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