EU MDR 2017/745 GENERAL PUBLIC TRAINING 11.06./12.07./10.09./12.10./12.11./13.12.2021
(To calculate the correct time zone, please feel free to use the button “Time zone converter” and use Berlin as a reference European Time)
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.
• Opening remarks
• History and update about the status of implementation
• Economic Operators and their obligations
• Conformity Assessment Process
• Technical Documentation
• Clinical Evaluation
• Post-Market Surveillance and Reporting Requirements
• Q&A session
• Closing remarks
- Start 08:30 AM – End 05:30 PM. Attendees are recommended to login 15 min in advance.
In order to keep the training interactive, the exact content schedule cannot be provided
Certification:Personal Certificate will be provided in PDF
Presentation:Presentation will be provided in PDF