Home / Online GXP courses / Medical Devices / IVDR Training : In Vitro Diagnostic Medical Devices Regulation 2017/746
Successful completion provides learners with a dated, traceable and downloadable certificate for the course :
Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.
Who should enroll?
This course is designed for professionals in the IVD medical device sector. It is ideal for those in regulatory affairs, design & development, quality management/assurance, quality engineering, internal auditing, authorized representatives, and PRRCs.
Learning Objectives:
By the end of this course, participants will be able to:
A certified course by GxP Training offers a highly interactive learning experience. Each session integrates real-life examples and quizzes. Upon completion, participants will receive a globally acknowledged training certificate, accredited with CPD/CEU credits.
Introduction
Lesson 1: Overview of the Regulation
Lesson 2: What is an In Vitro Diagnostic Medical Device?
Lesson 3: Classification of In Vitro Diagnostic Medical Device
Lesson 4: Economic Operator
Lesson 5: EUDAMED
Lesson 6: UDI & Registration
Lesson 7: Conformity Assessment
Lesson 8: Sufficient Clinical Evidence
Lesson 9: Post Market Surveillance
Conclusion
Evaluation
$95.00 / year
$95.00 / year
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