Overview

Comply Guru™ are proud to be partnering with Meddev Solutions in bringing to market 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!

Meddev Solutions are a team of QARA professionals, each with a minimum of 20 years’ experience, working in the medical device industry for both manufacturers and Notified Bodies.

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.

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 Snapshot

• Course Duration:

  18 Hours

• Continuing Education Units:

  1.8

• Format

  Online & Self-Paced Course

• Accreditation

  
  Exemplar Global Certified Course

• Delivery Options & Discounts

  • Discounts Available for 5+ Licenses. Request a Quote!

• Price

  1,375 (Pre-Order Rate Only)

• Fee Includes

  • Course Access for 90 days
  • Virtual Instructor Assistance – Phone & Email Support