FDAnews Announces — Usability Engineering: How the Updated ISO 14971:2019 Changes Your Process Webinar, Mar. 11, 2020

Share Article

Ensure device compliance by easily implementing the updated ISO 14971:2019 risk management standard for usability engineering.

WCG FDANews

WCG FDANews

Usability Engineering
How the Updated ISO 14971:2019 Changes Your Process
An FDAnews Webinar
Wednesday, March 11, 2020 • 1:30-3:00 p.m. EDT
https://www.fdanews.com/usabilityengineering

Is effectively implementing the updated ISO 14971:2019 risk management standard regarding usability engineering clear? If one designs or manages risk for medical devices, correctly incorporating the new standard is key to ensuring device compliance.

This webinar shares information one must know to implement the standard and consider and document reasonably foreseeable misuse errors — including abnormal use — in the risk assessment and risk management process. Attendees will identify safety issues before they derail devices employed by these solid usability engineering techniques.

Dan O’Leary, President of Ombu Enterprises, LLC will ensure attendees upgrade the usability engineering flow and link it to the new risk management standard. He’ll explain:

  • What one must know about the regulatory status of the standards in the U.S., EU and Canada
  • How to make ISO 14971:2019 work for the organization
  • How to stay complaint according to the FDA Center for Devices and Radiological Health’s (FDA-CDRH) approach to usability engineering
  • How to comply with the EU-MDR and EU-IVDR requirements for usability engineering
  • How to incorporate the concepts of formative and summative evaluation
  • Which inputs one must add to the user interface specification
  • What to include in terms of elements on the user interface evaluation plan

Bonus Material! Attendees will receive a checklist to ensure the use of a correct file structure for usability engineering.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about our special multisite discount.

Webinar Details:
Usability Engineering
How the Updated ISO 14971:2019 Changes Your Process
An FDAnews Webinar
Wednesday, March 11, 2020 • 1:30-3:00 p.m. EDT
https://www.fdanews.com/usabilityengineering

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/usabilityengineering
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

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Michelle Butler
FDAnews
703.538.7600
Email >
Visit website