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Online & Self-Paced Risk Management & ISO 14971:2019 Training Course | Exemplar Global Certified

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Overview

This Exemplar Global Certified online & self-placed course will offer an interactive, comprehensive overview of risk management to medical devices based on ISO 14971:2019.

Comply Guru™ are proud to be partnering with leading EU Medical Device Regulation (MDR) Experts, Meddev Solutions UK, in bringing to market this exciting new online & self-paced course!

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

For more information and a detailed overview of the course content, please view the Course Content tab below.

Course Snapshot

  • Course Duration:

    8 Hours

  • Continuing Education Units:

    0.8

  • Format

    Online & Self-Paced Course

  • Accreditation

    CQI and IRCA approved training partner
    Exemplar Global Certified Course

  • Delivery Options & Discounts

    • Discounts Available for 5+ Licenses

  • Price

    595.00 incl. Certification Fees

  • Fee Includes

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

How to Purchase Course Content Certification Who Should Attend How Will I Be Assessed Our Instructor Entry Requirements Technology Requirements

This course is online, self-paced & available 24/7

Learn Anytime, Anywhere - launches March 17th 2021

Start DateLocationCostDurationActionsVolume License
Anytime

Anywhere

 $595
8Hours

  • Module 0: Introduction

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

  • 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 and Risk Management Techniques

    • 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

This course is fully certified by Comply Guru™ & Meddev Solutions.

In order to successfully complete the course, each Learner will need to obtain a grade of 70% or higher in the final examination. Successful completion will entitle each Learner to receive a certificate of completion.

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:

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

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 Assessment)
  • Instructor Image
    Breda Kearney

    Breda leads the design of Comply Guru’s internationally accredited CQI & IRCA Certified Online & Blended Training Programs.

    Read More

  • Instructor Image
    Rod Beuzeval

    Rod has worked in Pharmaceutical and Medical Device sectors for over 19 years and holds a degree in engineering.

    Read More

Recommended Prior Knowledge:

  • Working knowledge of medical device quality management systems

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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The Numbers - How We Are Doing

  • 100%

    Our Pass Rate

  • 100%

    Would Recommend Comply Guru

  • 99%

    Gave us 4/5 Stars or higher Overall Training Experience

  • 95%

    Would Recommend Online or Blended Training over Classroom Training

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