Online & Self-Paced Comprehensive EU In-Vitro Diagnostic Regulation (EU-IVDR 2017/746) Practitioner Course

Comply Guru™ are proud to introduce this Exemplar Global certified Comprehensive EU In-Vitro Diagnostic Regulation (EU-IVDR 2017/746) Practitioner Course – it will be the first and most comprehensive online & self-paced course to be released in the world!

Our course provides an in-depth foundation on the key principles and practices required for the new European In-Vitro Diagnostic Regulation (IVDR) 2017/746.

Learning Objectives

There are 7 course objectives:

1. Explain the history, purpose and structure of the EU IVDR, and the key terminology used throughout the regulation
2. Identify the types of device covered by the EU IVDR, the rules for classification and the routes to conformity
3. Describe the obligations of the economic operators and the PRRC
4. Describe the General Safety & Performance Requirements
5. Outline the requirements for Performance evaluation and Performance studies
6. Explain the Post Market Surveillance and Vigilance reporting requirements
7. Describe the contents of the Technical Documentation and explain the Unique Device Identifier requirements

Course Certification

This course will be offered with Exemplar Global certification, under our RTP approval. Successful completion will entitle each Learner to receive a digital  Exemplar Global Recognized Certificate of Achievement.

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

Assessment Methodology

In order to successfully complete this online course, each Learner will need to:

• Complete the online course modules and obtain 70% or higher in the assessments (MCQ-based)

Course Access & Support

Upon registering for this course, a Learner will be able to avail of the following:

• Course Access for 90-days
• Phone & Email Support (Virtual Instructor)