Date: Multiple dates available below
Time: 08:30 AM to 05:30 PM (Central European Daylight Time GMT + 2)

(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: 8 hours
Location: Virtual Event
Language: English
Fee: 699 €


The Standard ISO 13485:2016 on Medical devices – Quality management systems – Requirements for regulatory purposes got updated in 2016. The ISO 13485:2016 / EU IVDR QMS training will give the attendees insight into the requirements of the European Union In Vitro Diagnostic Medical Device Regulation (“IVDR”, (EU) 2017/746) related to the quality management system as well as an overview of the international standard
ISO 13485:2016. A major focus will be on what is new in both, the IVDR as well as the ISO 13485:2016, and how (EU) IVDR and ISO 13485:2016 relate & complement each other. Through this training, you will gain an understanding of applicable regulatory requirements (IVDR) and get insight on the concepts established in the ISO 13485:2016 for Quality Management Systems of players in the IVD medical device field, all while gaining proof of competence from subject matter experts.


• Opening remarks
• ISO 13485:2016 QMS requirements for regulatory purpose
o New elements
o Management Responsibility
o Resource Management
o Product Realization
o Measurement, analysis, and improvement
• QMS according to IVDR, (EU) 2017/746
o New compared to the IVDD, 98/79/EC
o Economic Operators
o Technical Documentation, incl. Performance Evaluation
o Conformity Assessment
o PMS, and Vigilance
• Relations between ISO 13485:2016 and IVDR
• 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.


Personal Certificate will be provided in PDF


Presentation will be provided in PDF

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