FDAnews Announces — Are You Ready for ISO 14971:2019? Manage Changes to Your Risk Management Systems Webinar, June 24, 2020

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Prepare to implement ISO 14971:2019’s revised requirements. Here’s how to manage changes to a risk management system.

WCG FDAnews

WCG FDAnews

Are You Ready for ISO 14971:2019?
Manage Changes to Your Risk Management Systems
An FDAnews Webinar
Wednesday, June 24, 2020, 1:30-3:00 p.m. EDT
https://www.fdanews.com/ISO14971201

With the FDA recognizing ISO 14971:2019 as the consensus standard, it’s not enough to learn the differences between the previous ISO 14971 Medical Devices–Application of Risk Management to Medical Devices and the currently published revision, or the soon-to-be-published supporting guidance document (ISO TR 24971).

How will one be impacted by ISO 14971:2019? Rethink the way one does risk management. What procedural changes should one make, other than changing the references in SOPs?

Be ready to implement the revised requirements in ISO 14971:2019 and EN ISO 14971:2019 within a risk management system by December 2022.

This presentation, given by a member of ISO/TC 210 JWG1, which developed ISO 14971 Medical Devices, Application of Risk Management to Medical Devices, is an opportunity to get best practices and guidance to meet the revised requirements and optimize risk management systems.

Christine “Tina” Krenc, who is also the principal consultant for KTA Compliance Consulting, will explain how to manage required changes to a risk management system:

Best practices and guidance to meet ISO 14971:2019’s revised requirements

  • Determine what is a benefit and how to gather that information and document it
  • Understand the difference between the policy for determining risk acceptability criteria and risk acceptability criteria and where and how one decides on it
  • Align the new guidance with an in-vitro diagnostic (IVD) medical device risk management system.

Examples and best practices to address frequently asked questions

  • How does one build a risk trace matrix?
  • How does one review overall residual risk of my product?
  • How does one use a risk management file during production and post-production?

Come away with an understanding of far more than just the differences between old and new. Be equipped to manage any required changes to a risk management system, so one can stay compliant.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
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Webinar Details:
Are You Ready for ISO 14971:2019?
Manage Changes to Your Risk Management Systems
An FDAnews Webinar
Wednesday, June 24, 2020, 1:30-3:00 p.m. EDT
https://www.fdanews.com/ISO149712019

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/ISO149712019
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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Michelle Butler
FDAnews
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