Online Comprehensive EU Medical Device Regulation/MDR 2017/745 Practitioner Course | CQI, IRCA & Exemplar Global Certified

★★★★★
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  • Course Area:

    Medical Devices

  • Continuing Education Units (CEUs):

    2.0

  • Course Duration:

    20 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

New! Online Comprehensive EU MDR Practitioner Course!

In this video, Eoin provides an overview of our new Comprehensive EU Medical Device Regulation (MDR) Practitioner Course – Check it out!

Watch Video

Comply Guru™ are proud to be partnering with Meddev Solutions in bringing to market this CQI, IRCA & Exemplar Global certified Comprehensive EU Medical Device Regulation (MDR) 2017/745 Practitioner Course – it is the first and most comprehensive online & self-paced course to be released in the world!

Our online, self-paced course can take you through the regulation, not just from an industry perspective, but also from a Notified Body perspective, which means you get the benefit of understanding what both sides are looking for. This course will focus on the overview & application – it isn’t just a simple ‘read and understand,’ it is a practical ‘how to’ guide, which you can actually use immediately.

Learning Objectives

On completion, successful Learners will have the knowledge needed to:

  1. Explain the history, purpose and structure of the EU-MDR, and the key terminology used throughout the regulation
  2. Identify the types of devices covered by the EU-MDR and the rules for classifying these devices
  3. Describe the obligations of the economic operators and the PRRC
  4. Describe the General Safety & Performance Requirements and the key features of a risk management system based on ISO 14971
  5. Describe the contents of the Technical Documentation and the requirements for Post Market Surveillance, Vigilance and Clinical Data
  6. Explain the Unique Device Identifier requirements and the relationship with Eudamed

Certification

This course is certified by Exemplar Global under the RTP Program, plus this course is certified by CQI & IRCA (No. 2378). Successful completion will entitle each Learner to receive a digital CQI, IRCA & Exemplar Global Recognized Certificate of Achievement.

Who Should Attend?

  • Quality assurance professionals
  • Quality Engineers
  • Research and design Engineers
  • Internal Auditors
  • Quality Managers
  • Manufacturing Engineers
  • Regulatory professionals

Assessment Methodology

  • Complete the online, self-paced course modules and obtain 70% or higher in three final assessments (MCQ-based Assessments)
  • This course is available in three parts, each with its own final assessment at the end of each part. A Learner may only progress to the next part upon successful completion of the previous part as the learning is progression based (sequential).

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 (Online & Self-Paced)

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

  • Module 1: Introduction to the EU-MDR (Online & Self-Paced)

    • History of the EU-MDR
    • Purpose of the EU-MDR
    • Structure of EU-MDR
    • Key Terminology
    • Key EU-MDR changes
    • EU-MDR Timelines for transition

  • Module 2: Medical devices covered by EU-MDR (Online & Self-Paced)

    • What is a device?
    • Devices in scope
    • Devices out of scope
    • Non-Medical devices

  • Module 3: Placing a Device on the Market (Online & Self-Paced)

    • Overview of Chapter II
    • Articles 5-9
    • Economic Operator & PRRC Responsibilities
    • Articles 16-24

  • Module 4: Device Classification (Online & Self-Paced)

    • Overview of Annex VIII
    • Class Types
    • Classification Rules

  • Module 5: Routes To Conformity (Online & Self-Paced)

    • Overview of Conformity Annexes
    • Annex IX
    • Annex X
    • Annex XI
    • Custom Made Devices
    • Notified Body Articles & Annexes

  • Module 6: GSPR & Risk Management (Online & Self-Paced)

    • Overview of Annex I
    • Chapter I General Requirements
    • Risk Management (ISO 14971, Chapter II Design & Manufacture
    • Chapter III Device Information

  • Module 7: Clinical Evaluation (Online & Self-Paced)

    • Overview of the Clinical Evaluation requirements including Article 61-62 and Annex XIV

  • Module 8: Post Market Surveillance & Vigilance (Online & Self-Paced)

    • Overview of PMS Articles 83-86
    • Overview of Vigilance Articles 87-89

  • Module 9: Technical Documentation, UDI and Eudamed (Online & Self-Paced)

    • Annex II and Annex III Technical documentation
    • Unique Device Identification (Annex VI)
    • UDI Timelines
    • Overview of Eudamed

    Course Entry Requirements

    Before completing this course, each Learner should have the following prior knowledge:

    ISO 13485

    •  Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified MD-QMS ISO 13485:2016 Foundation (FD132) training course or equivalent.

    Medical Device Management Systems

    Knowledge of the following quality management principles and concepts:
    • The relationship between ISO 13485 and the EU-MDR 2017/745
    • Commonly used quality management terms and definitions within ISO 13485 and ISO 9000
    • A working knowledge of risk management principles related to the design of a medical device, through ISO 14971

    Technology 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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