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ISO 14971:2019 Update Training

Need to get up to speed on ISO 14971:2019? Then this is the class for you!

Course participants must already have working knowledge and skills with the ISO 14971:2007 and EN ISO 14971:2012 revisions.  

ISO 14971:2019 was released in December of 2019. The updated standard provides new definitions and clarifications of the Risk Management process and more fully explains how to align your Risk Management system to ISO 13485:2016 and the EU MDR 2017/745. Not only that, but ISO/TR 24971:2020 has been completely overhauled to align with these changes, so you’ll need to understand how these two documents work in tandem.

This course provides an in-depth review of what is different in ISO 14971:2019 and ISO/TR 24971:2020 and sets participants on the path to update their risk management system to align with the changes.

If you’re new to risk management and looking for in-depth training, consider this class.

 

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Course Date

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.
There are currently no public dates scheduled. All our courses are available to be held at a location of your choice. Please contact us for more information.

Course Detail

Objectives

At the end of this workshop, participants will be able to:

  • Describe the impact of changes in ISO 14971:2019 and ISO/TR 24971:2020
  • Compare ISO 14971:2019 and Annex I of the EU regulations (EU MDR 2017/745, IVDR 2016/746)
  • Identify best practices for planning your organization’s risk management system upgrade
  • Virtual Half-Days

    2
  • In-Person Full-Days

    1
  • CEUs

    0.8

Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX Virtual Instructor-Led Training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

Online Training Schedule

  • This training is delivered as 2 consecutive half-day sessions.
  • Daily sessions run from 1:00-5:00 p.m. Eastern Time. 
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • PC MAC Computer

    PC or MAC Computer

  • Reliable Internet

    Reliable Internet

  • Video Webcam

    Video Webcam

  • Headset or Earbuds

    Headset or Earbuds

  • Quiet Setting

    Quiet Setting

  • Two Monitors Recommended

    Two Monitors

 

Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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