ISO 14971:2019 Risk Management Requirements Workshop – Virtual April 2024

Course Summary

This course is designed for Internal Auditors, Quality Assurance Managers, ISO 13485:2016 Implementation Team Members, Management Representatives, and individuals who wish to learn how to apply risk management tools and techniques utilizing ISO 14971:2019 and ISO 24971:2020.

$477.00

April 25, 2024 - April 26, 2024

Event Details

8 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually

Start date: April 25, 2024

End date: April 26, 2024

Start time: 08:30 a.m. EDT

End time: 04:30 p.m. EDT

Venue: Virtual on Zoom

Directions: Training will occur on Zoom. You will be provided with a unique link per registrant. Please plan to login 10 minutes prior to the session start time.

Description

ISO 14971:2019 “Medical devices — Application of risk management to medical devices” defines a standard process for identifying risks associated with medical devices at all stages in a device’s life cycle, from product design to production and post-production use. The goal of ISO 14971 training is to develop a risk management plan that prioritizes that an effective quality system should systematically identify, analyze, evaluate, control, and monitor risk throughout the product life cycle to ensure that the devices are safe and effective.

To help understand ISO 14971:2019, the course will use ISO 24971:2020 “Medical devices— Guidance on the application of ISO 14971” which is a companion document. Tools and techniques described in ISO 24971:2020 will be used to demonstrate how risks can be assessed and evaluated.

Risk management is a key focus of the new QMSR regulation, with an emphasis on integrating risk management principles throughout the QMS. Manufacturers need to fully understand the relationship between ISO 13485 and ISO 14971, with a focus on life cycle risk management starting from design to post-market to ensure full compliance with the new regulation that goes live in 2026. In alignment with this regulatory advancement, FDA is proactively training pre-market and post-market CDRH personnel on both ISO 13485 and ISO 14971. If you work in medical devices, this is your call to action: get trained on ISO 13485:2016 and ISO 14971:2019.

What does this mean practically for industry? Compliance with every part of ISO 13485:2016 that explicitly discusses risk management is required and could be subject to regulatory inspection and consequences for noncompliance. The totality of the risk management system that wraps around and enhances all the risk-related clauses in ISO 13485 is highly suggested (by FDA) to be designed to comply with ISO 14971.

Who Should Attend

This course is designed for Internal Auditors, Quality Assurance Managers, ISO 13485:2016 Implementation Team Members, Management Representatives, and individuals who wish to learn how to apply risk management tools and techniques utilizing ISO 14971:2019 and ISO 24971:2020.

Learning Objectives

Through training, participants will learn:

  • QMSR (Quality Management System Regulation) – Risk Management requirements
  • Describe the Risk Management Process as defined in ISO 14971:2019
  • Identify how ISO 14971:2019 relates to ISO 13485:2016 Risk Management Requirements
  • Leverage the relationship of ISO TIR 24971:2020 to ISO 14971:2019
  • Identify and Quantify Risks for their Organization
  • Apply Risk Management Tools and how they align with the Product Life Cycle and requirements in ISO 13485:2016

Course Outline

  1. Applicability of ISO 14971:2019
  2. Structural Changes of ISO 14971:2019
  3. Changes and Additions to ISO 14971:2019
  4. Changes and Additions to ISO 24971:2020
  5. Detailed Analysis of ISO 14971:2019 with reference ISO 24971:2020 Tools and Techniques
    • Clause 1 – Scope
    • Clause 2 – Normative References
      • Clause 3 – Terms and Definitions
      • Exercise #1 – Terms & Definitions
    • Clause 4 – General Requirements
      • Risk Management Plan – Example
    • Clause 5 – Risk Analysis
    • Clause 6 – Risk Evaluation
      • Tools during Product/Service Life Cycle
      • Exercise #2 – Supplier Risk Assessment (ISO 13485)
    • Clause 7 – Risk Control
      • Control Options
      • Benefit-Risk Examples
    • Clause 8 – Evaluation of Overall Risk
    • Clause 9 – Risk Management Review
      • Overall/Total Residual Risk
      • Risk Management Review
    • Clause 10 – Production and post production activities
    • ISO 13485:2016 and Risk Management
      • Exercise #3 – Risk Application – Customer Complaints
      • Exercise #4 – Training Exercise – Risk
    • ISO 14971:2019 Conclusions

Prerequisites

None

Instructors

Webinar Testimonials

0
    Your Cart
    Your cart is emptyReturn to Shop
    Reap the benefits

    Login with your Membership Credentials

    Not Yet a Member? Request Membership Now

    Interested in this course for the Future?

    Thanks for letting us know!
    Please fill in the information below so that we can keep you informed.
    Name
    I'm not registering yet because



    Introducing our Updated Website Designed to Enhance your Experience

    Explore our revamped website and experience a more user-friendly interface designed to serve you better!

    Thank you for visiting QSG!

    If you have any questions, would like more information, or would like to speak with a QSG representative, please contact us at any time!