Online & Self-Paced Comprehensive EU In-Vitro Diagnostic Regulation (EU-IVDR 2017/746) Practitioner Course
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Online & Self-Paced Comprehensive EU In-Vitro Diagnostic Regulation (IVDR) 2017/746 Practitioner Course
In this brochure you will learn about:
- Coruse Overview & Content
- Assessment Methodology
- Certification
- Our Management Team & Experts
- How You Will Learn with Comply Guru
- How To Contact Us
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Course Area:
Medical Devices
Continuing Education Units (CEUs):
1.8
Course Duration:
18 Hours
Accreditation:
Format:
Online & Self-Paced Course
Individual Pricing:
1,495.00 per person
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!
Watch VideoComply 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!
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:
- Explain the history, purpose and structure of the EU IVDR, and the key terminology used throughout the regulation
- Identify the types of device covered by the EU IVDR, the rules for classification and the routes to conformity
- Describe the obligations of the economic operators and the PRRC
- Describe the General Safety & Performance Requirements
- Outline the requirements for Performance evaluation and Performance studies
- Explain the Post Market Surveillance and Vigilance reporting requirements
- 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)
About Meddev Solutions
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.
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 IOS10Mobile 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 contentRecommended Internet Browsers
- Google Chrome 32 bit version 50 or later
- Safari 10 or later
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
