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Medical Device Risk Management: Implementing ISO 14971:2019

Tuesday, Dec. 1, 2020 • 10:00 a.m. - 4:30 p.m. EST | Presented by FDAnews and Ombu Enterprises

Risk management is just plain hard — complicated, conflicted, confusing. And it’s getting harder.

ISO 14971 is being revised. While the changes aren’t intended as “major”, the new standard adds new definitions… changes the clause numbering… introduces new requirements… changes many of the annexes and moves them to a new document.

And at the same time the EU is in transition to new regulations. There are new concepts… new risk reduction requirements… and new applications. Two areas of impact are side effects (residual risk) and benefit-risk analysis as a life-cycle requirement.

Are you prepared for these changes? Have you worked on risk analysis and evaluation with your team? Are your risk management files and plans up-to-date?

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

Your risk management guide, Dan O’Leary, 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.

Virtual conference takeaways: 

  • 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 your current risk management systems and a deep understanding of where they need to go. Let us help make that process simpler and more successful.

Join us for this virtual workshop by registering today.


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Who Will Benefit

  • Medical device manufacturers
  • Device companies seeking to market products in the EU
  • Quality professionals
  • Regulatory affairs professionals
  • QSR staff
  • Inspections and audits staff
  • Post-market safety staff
  • Submissions and approvals professionals
  • Research and development teams
  • Commercial operations staff

Meet Your Presenter

Dan O

Dan O'Leary


Ombu Enterprises LLC

Dan O’Leary, president of Ombu Enterprises, LLC, has more than 30 years of experience in quality, operations and program management in regulated industries, including aviation, defense, medical devices and clinical labs. Ombu Enterprises, LLC, offers training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. O’Leary has a master’s degree in mathematics and is an ASQ-certified biomedical auditor, quality auditor, quality engineer, reliability engineer and Six Sigma black belt.

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