EU MDR 2017/745 General Public Training with Dr. Bassil Akra 12.10.2020

Date: 12.10.2020
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 medical device regulation was published in 2017 with a transition period three years. Due to COVID-19 a delay of 1 year was applied by the EU Legislators ensuring a reasonable implementation of the regulation. Notified bodies will require training records of your resources when conducting initial certification audits of your organization. Don´t wait long and use the additional year to get your resources prepared.

Topics:

  • History and update about the status of implementation
  • Economic Operators and their obligations
  • Classification
  • Conformity Assessment Process
  • Technical Documentation
  • Clinical Evaluation MDCG
  • Post-Market Surveillance and Reporting

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

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