Comprehensive EU IVDR 2017/746 Practitioner Course
100% Online. No hidden fees. In Partnership with Comply Guru. Available September 2021. Pre-order now and SAVE!
We are very proud to be bringing to market this Exemplar Global 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 an Exemplar Global certified certificate. Course Accreditation is held by Comply Guru.