16-hour In Vitro Diagnostic Medical
Device Regulation (IVDR) Foundation Course (EU) 2017/745
Our 16-hour course provides an introduction to the application of the key principles and practices required for the new In Vitro Diagnostic Medical Devices Regulation.
The course is designed to enhance the level of understanding for those actively engaged with IVDs and placing them on the market.
This course is fully certified by Comply Guru™ & Meddev Solutions.
In order to successfully complete the course, you will need to obtain a grade of 70% or higher in the final multiple choice examination. Successful completion will entitle you to receive a certificate of completion.
This course is being released in November 2020.
Learning Objectives:
▪ Gain a solid understanding of the safety and performance requirements
▪ Know the requirements for manufactures and economic operators
▪ Understand post-market surveillance and the associated reports
This course has great value for
anyone involved in implementing
or maintaining regulatory
compliance with the new
regulation.
Who should attend?
▪Quality Assurance professionals
▪Quality Engineers
▪Research and Design Engineers
▪Internal Auditors
▪Quality Managers
▪Manufacturing Engineers
▪Regulatory professionals
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