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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. 


Applying a Risk-Based Approach to Biological Evaluation of Medical Devices Based on the Framework of ISO 10993-1:2018 June 22, 2021, 06:15 PM
Helin Raagel Senior Biocompatibility Expert, Nelson Labs
Risk Management For Executives: Why Does it Matter to Me? June 23, 2021, 04:00 PM
Michael Cremeans Life Sciences Industry Practice Leader, Hylant
How to Apply Risk Management Throughout the Product Lifecycle of your Medical Device June 22, 2021, 04:15 PM
Mike Baca President, White Rook Consulting
How to Implement Risk Management into Regulatory Submissions Using Tips, Tricks, and Standards to Satisfy FDA Concerns June 22, 2021, 05:15 PM
Mary McNamara-Cullinane Senior Vice President of Regulatory Affairs, Alira Health

This True Quality Summit Series is Highly Recommended For:

• Medical Device Executives & Leadership Teams

• Quality Professionals and Management

• Regulatory Affairs Professionals and Management

• Clinical Affairs Professionals and Management

• R&D Engineers and Management

Meet the speakers

The Risk Management True Quality Summit Series is for you if you are looking to:

• 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

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