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:
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Explain the history, purpose and structure of the EU IVDR, and the key terminology used throughout the regulation
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Identify the types of device covered by the EU IVDR, the rules for classification and the routes to conformity
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Describe the obligations of the economic operators and the PRRC
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Describe the General Safety & Performance Requirements
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Outline the requirements for Performance evaluation and Performance studies
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Explain the Post Market Surveillance and Vigilance reporting requirements
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Describe the contents of the Technical Documentation and explain the Unique Device Identifier requirements
Course Content
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
▪ PRRCs
Self-Paced
100% Online
Tutor Support
Accessible from any device 24/7
Exemplar Global Certified
Formal Assessment And Certification
Course Price
This course is €1,115 €1,000* One price, no hidden fees.
You can start this course on the 1st of September 2021.
This price includes:
▪ Course access for 90 days
▪ Phone and email tutor support
▪ Exemplar Global assessment and certification fee
Multi-Person Discount: Buy 3 courses & get a 4th FREE!
*Limited time discount
Duration
This course takes 18 hours to complete.
Certification
Upon successful completion of the course you will receive a globally recognised certificate.