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

★★★★★

  • Course Area:

    Medical Devices

  • Continuing Education Units (CEUs):

    1.8

  • Course Duration:

    18 Hours

  • Accreditation:

    CQI and IRCA approved training partner
  • Format:

    Online & Self-Paced Course

  • Individual Pricing:

    1,495.00 per person

  • Team Pricing:

    6355.00 (5-Pack)

    Need more! Call us

Finally, an industry-leading online & blended training solution for ISO Standards, Quality Auditing & Medical Device Training!

Comply Guru LLC, based in Chicago, IL, offers a growing portfolio online & blended training courses on various ISO Standards, Quality Auditing and Medical Device Regulations to enable its Learners to get the knowledge and skills they need from home, work or anywhere!

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Comply Guru™ are proud to launch 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)
  • Module 0: Course Introduction

    • Accessibility & Player Features
    • Course Objectives
    • Course Description
    • Module Structure
    • Assessment
    • Meet Our Partner and Expert
    • Learner Support
    • Available Resources

  • Module 1: Introduction to the IVDR

    • Purpose of the IVDR
    • Structure of IVDR
    • Key Terminology
    • IVDR v IVDD – Key Changes
    • IVDR Timelines for transition

  • Module 2: Devices covered by IVDR

    • What is an in-vitro medical device?
    • Devices in scope
    • Devices out of scope
    • Relationship with machinery and atomic energy directive

  • Module 3: Placing a Device on the Market

    • Chapter II Terminology
    • Articles 5-9
    • Economic Operator & PRRC Responsibilities
    • Articles 16-21

  • Module 4: Device Classification

    • Implementing Rules
    • Classification Rules 1-7

  • Module 5: Routes to Conformity

    • Conformity assessment annexes IX, X, XI
    • Article 48 Devices categories and groups
    • Special device conformity
    • Derogation from conformity assessment
    • Notified Bodies

  • Module 5: GSPR & Risk Management

    • Overview of Annex I
    • Chapter I General Requirements
    • Risk Management (ISO 14971)
    • Chapter II Performance, design & manufacture
    • Chapter III Device information

  • Module 7: Performance Evaluation and Performance Studies

    • Article 56 & 57
    • Performance study articles
    • Annex XIII Part A
    • Annex XIII Part B
    • Annex XIV
    • Summary of safety and performance

  • Module 8: Post Market Surveillance & Vigilance

    • Post market surveillance articles 78-81
    • Vigilance terminology
    • Vigilance reporting
    • Trend reporting
    • Analysis of serious incidents and FSCA
    • Data analysis

  • Module 9: Technical Documentation, UDI and EUDAMED

    • Annex II & III, UDI terminology
    • Annex VI, UDI timelines
    • EUDAMED databases
    • EUDAMED timelines
    • MDCG

    E-Learning System Requirements

    The below are the recommended requirements for each Learner in wishing to complete any of our online training courses or modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS)  may be impacted, restricted and may not perform well.

    Recommended Operating Systems

    Windows 7/10, Mac OSX Sierra, iPad IOS10

    Mobile Devices

    Comply Guru’s LMS is not available on a mobile app at this time. We recommend using a web browser on a mobile device in completing any online modules. However, if completing any final graded assessment, we recommend completing via a desktop browser.

    Internet Speed

    We recommend using an internet connection of 256Kbit/sec or faster that will ensure that you can view videos and the online content

    Recommended Internet Browsers

    • Google Chrome 32 bit version 50 or later
    • Safari 10 or later
    Important Note: add-ons and toolbars can affect any browsers performance. MS Internet Explorer or Edge is not recommended as its not compatible with the LMS and the course functionality will not work properly.

    Recommended Settings

    We recommend that the following settings are enabled:
    • Cookies
    • Pop-ups (in both Internet Browser and security software)
    • JavaScript
    • Plugins
    • Latest Version of Adobe Flash Player
    • Latest Version of Adobe Acrobat Reader
    To view all resources made available within our LMS, you will probably need Microsoft Office (Word, Excel, PowerPoint) or an equivalent (i.e Open Office, Viewer) installed.

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