Online & Self-Paced Medical Device Risk Management & ISO 14971:2019 Training Course | CQI, IRCA & Exemplar Global Certified

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  • Course Area:

    Medical Devices

  • Course Duration:

    8 Hours

  • Format:

    Online & Self-Paced Course

  • Accreditation:

    CQI and IRCA approved training partner
  • Individual Pricing:

    495 per person

  • Team Pricing:

    Need more! Call us

Explainer Video for Risk Management & ISO 14971:2019 Course

This new video introduces our new Online & Self-Paced Risk Management & ISO 14971:2019 for Medical Devices Training Course including an overview of the course content and who this course was designed for.

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This CQI, IRCA & Exemplar Certified Online & Self-Paced Medical Device Risk Management & ISO 14971:2019 Training Course will offer an interactive, comprehensive overview of risk management to medical devices based on ISO 14971:2019.

Learning Objectives

There are 6 course objectives covered:

  1. Explain the history, purpose and structure of ISO 14971 and its relationship to ISO 13485 and the EU & US FDA regulations
  2. Define the key terminology used throughout ISO 14971
  3. Describe the elements of an effective risk management process
  4. Describe the different techniques that support risk analysis
  5. Explain the requirements for updating the risk assessment based on information collected and reviewed
  6. Outline the role of ISO/TR 24971 in risk management

Course Certification (No. 2415)

This course is CQI, IRCA & Exemplar Global Certified. Successful completion will entitle each Learner to receive a digital CQI, IRCA & Exemplar Global Recognised Certificate of Completion.

Who Should Attend?

This course is aimed at anyone working in the medical device sector that wants to gain an understanding of risk management based on ISO 14971:2019, including:

  • Design & Development personnel
  • Quality / Engineering / Technical / Production personnel
  • Regulatory affairs
  • Internal / Lead / Supplier Auditors

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: Introduction

    • Accessibility & Player Features
    • Course Description and Duration
    • Module Structure
    • Course Objectives
    • Assessment Methodology
    • Instructor Support
    • Required Standards
    • Available Resources
    • Learner reflection

  • Module 1: Introduction to Risk Management

    • Purpose, History and Structure of ISO 14971,
    • Key Changes introduced by ISO 14971:2019
    • Key Terminology
    • Relationship with ISO 13485, MDR 2017/745, IVDR 2017/746 and 21 CFR part 820
    • Risk Management and the Product Lifecycle

  • Module 2: Risk Management Planning

    • Risk Management Process
    • Risk Management Team
    • Role of Top Management
    • Risk Management Plan
    • Risk Management File

  • Module 3: Risk Analysis and Evaluation

    • Device Characterization
    • Hazards and Hazardous Situations
    • Risk Estimation
    • Risk Evaluation

  • Module 4: Risk Control

    • Risk Management Techniques – PHA, FTA, FMEA HAZOP
    • Risk Control Analysis
    • AFAP and ALARP
    • Implementation of Risk Controls
    • Residual Risk
    • Benefit – Risk Analysis

  • Module 5: Risk Management Review

    • Overall Residual Risk Evaluation
    • Risk Management Review
    • Production and Post-Production Activities

  • Module 6: ISO/TR 24971

    • Purpose of ISO/TR 24971
    • Structure of ISO/TR 24971
    • Overview of Key Annexes

    Course Entry Criteria

    Before completing this course, each Learner is recommended to have the following prior learning: Risk Management
    • The fundamental concepts and principles of risk management as it applies to medical devices
    • The commonly used risk terms and definitions (see ISO 14971)
    ISO 13485:2016
    • A working knowledge of ISO 13485:2016, which may be gained by completing Comply Guru’s CQI & IRCA Certified ISO 13485:2016 Foundation Course

    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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