WCG FDAnews

WCG FDAnews

Medical Device Risk Management:
Implementing ISO 14971:2019
A Virtual Workshop Presented by FDAnews and Ombu Enterprises
Tuesday, Dec. 1, 2020, 10:00 a.m. – 4:30 p.m. EST
https://www.fdanews.com/mdriskmanagement

ISO 14971:2019 is changing the standards around risk management — and the introduction of the EU-MDR is only making things more complicated. This process has never been simple but having to adjust clause numbers, documentation and risk-management systems while successfully merging the two new sets of expectations adds extra challenges.

How does one prepare for these changes? Has the team worked on risk analysis and evaluation? Are the risk management files and plans up-to-date?

This Medical Device Risk Management virtual workshop on Dec. 1 will cover everything needed to implement an efficient and effective risk management system. Through expert advice, attendees will gain a basic understanding of medical device regulations, discover how ISO 14971:2019 will impact procedures and work to identify gaps in implementation plans.

The risk management guide is Dan O’Leary, a favorite presenter at dozens of FDAnews-sponsored workshops. Dan will share tips on how to define acceptable risk, create a risk management plan, and complete an overall residual risk evaluation. He’ll also share how these requirements connect to the EU-MDR and what organizations need to do to match the two standards.

During this virtual workshop, attendees will cover:

  • Basic medical device regulations and standards
  • Risk management files and plans
  • Acceptable risk definitions and the risk matrix
  • Risk analysis, evaluation and control
  • Residual risk evaluation
  • Risk management review
  • Production and post-production requirements
  • EU-MDR adjustments and expectations
  • ISO 14971:2019 implementation and process standards
  • Annex I risk-specific requirements

Implementing ISO-14971:2019 will require a careful look at one’s current risk management systems and a deep understanding of where they need to go. This virtual workshop can make that process simpler and more successful.

Want to share this experience with your colleagues?
Ask us about our tiered discounts for multiple participants!

Virtual Workshop Details:
Medical Device Risk Management:
Implementing ISO 14971:2019
A Virtual Workshop Presented by FDAnews and Ombu Enterprises
Tuesday, Dec. 1, 2020, 10:00 a.m. – 4:30 p.m. EST
https://www.fdanews.com/mdriskmanagement

Tuition:
$597 per person
Multiple attendee discounts are available

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