Comprehensive EU IVDR 2017/746 Practitioner Course
100% Online. No hidden fees. Available September 2021. Pre-order now and SAVE!
We are very proud to be bringing to market this certified Comprehensive EU IVDR 2017/746 Practitioner Course.
This is the first and most comprehensive online, self-paced course to be released in the world on the EU IVDR!
This course will give you an in-depth foundation on the key principles and practices required for the new EU IVDR 2017/746.
There are 7 course objectives:
Explain the history, purpose and structure of the EU IVDR, and the key terminology used throughout the regulation
Identify the types of device covered by the EU IVDR, the rules for classification and the routes to conformity
Describe the obligations of the economic operators and the PRRC
Describe the General Safety & Performance Requirements
Outline the requirements for Performance evaluation and Performance studies
Explain the Post Market Surveillance and Vigilance reporting requirements
Describe the contents of the Technical Documentation and explain the Unique Device Identifier requirements
In this course, you will cover 9 units:
▪ Introduction to the EU IVDR
▪ Devices covered by the EU IVDR
▪ Placing a Device on the Market
▪ Device Classification
▪ Routes To Conformity
▪ GSPR & Risk Management
▪ Performance Evaluation & Performance Studies
▪ Technical Documentation, UDI and Eudamed
▪ Post Market Surveillance & Vigilance
For the full list of topics covered please download the brochure.
Who should attend?
This course is aimed at anyone working in the in-vitro diagnostic medical device sector who is responsible for or involved in ensuring compliance to IVDR 2017/746 including but not limited to:
▪ Regulatory affairs
▪ Design and development
▪ Quality Management/Assurance
▪ Quality Engineers
▪ Internal Auditors
▪ Authorised Representatives
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