June 22-24, 2021

Risk Management True Quality Summit Series

Medical device risk management is not optional – it is a regulatory requirement worldwide.

But with today's medical device regulatory environment changing faster than ever, and the confusion that can come with Risk Management, it doesn’t mean it’s easy.

The Risk Management True Quality Summit Series will help quality, regulatory and product development professionals and executives understand and implement risk management concepts that can help meet FDA, ISO 14971, ISO 13485:2016, and the MDR 2017/745 requirements for risk management.

We’ll dive into the standards and outline deliverables at each stage of the risk management process, explore practical solutions for applying the standards within your organization, and ultimately give you tools to ensure risk management lives throughout your entire product life cycle. 


Who Owns Risk Management and How Does it Impact the Business? | Jon Speer

Documenting Risk Management to Meet Requirements of ISO 14971:2019 | Edwin Bills

How to Apply Risk Management Throughout the Product Lifecycle of your Medical Device | Mike Baca

How to Implement Risk Management into Regulatory Submissions Using Tips, Tricks, and Standards to Satisfy FDA Concerns | Mary McNamara-Cullinane

Applying a Risk-Based Approach to Biological Evaluation of Medical Devices Based on the Framework of ISO 10993-1:2018 | Helin Raagel

How Risk Management Can Help Drive Innovation | Michael Quinn

What to do When FMEA is Not Sufficient Anymore | Peter Sebelius

How to Predict Medical Device Recalls using Publicly Available Data | Mohammed (Bilash) Hossain and John Lorenc

Risk Management For Executives: Why Does it Matter to Me? | Michael Cremeans

Implementation of the Risk management Board for New Product Introduction and Post Market Surveillance | Mike Baca

By Design: Reduce Risk and Improve Compliance with a Layered Software Architecture | Cynthia Smith

Managing Risks Along an IVD-Analyzer’s Life-Cycle | Christoph Schär

Protecting your Data from Risk: To, From, and In the Cloud | Chris DuPont

What is the Best Way to Structure a Risk Management File | Carolyn Guthrie

MDR Date of Application Roundup: The New Landscape for Medical Device Manufacturers | Evangeline Loh

Risks that No One Wants to Talk About: Theoretical Risks Management vs. Life in the Real World | Michael Drues

How and When to Conduct Your First Hazard Analysis | Sarah Nixon

Watch the Summit Series

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Specifically, this summit series will cover:
  • Gain an understanding of what is expected from medical device regulators regarding Risk Management
  • Use Risk Management as a tool to design safer medical devices
  • Learn how to follow risk management guidelines and best practices outlined in the latest version of the ISO 14971 standard and accompanying technical report
  • Understand how ISO 14971:2019 relates to 21 CFR 820, ISO 13485:2016, and the MDR 2017/745
  • Understand HOW you should be doing risk management (not just the requirements
  • Learn How to incorporate risk management best practices with design control activities and other key quality subsystems (and why it matters)
  • Understand tips, tricks, and tactics to estimate risk for a medical device
  • Get actionable insights and trends on global risk management from Greenlight Guru’s original research report and learn how to apply them in your current role
Who should attend? 
  • Medical Device Executives & Leadership Teams
  • Quality Professionals and Management
  • Regulatory Affairs Professionals and Management
  • Clinical Affairs Professionals and Management
  • R&D Engineers and Management
Register Now  

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