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Understanding Risk in Medical Device New Product Development (NPD) - Featured Image

Understanding Risk in Medical Device New Product Development (NPD)

Editor's Note: This is a guest post by Jeff Groh, President at New Product Visions and was originall...
Why FMEA is NOT ISO 14971 Risk Management - Featured Image

Why FMEA is NOT ISO 14971 Risk Management

If you are still using FMEA as your methodology to capture medical device risk management activities...
4 Reasons Why Your Risk Management Approach is Wrong - Featured Image

4 Reasons Why Your Risk Management Approach is Wrong

This article originally appeared as a guest post on MedTech Intelligence. A few months ago, I predic...
The Risk Management + Design Controls Connection: What Device Makers Need to Know - Featured Image

The Risk Management + Design Controls Connection: What Device Makers Need to Know

This eBook was originally published as a guest expert three, part, series on Med Device Online.   Yo...
Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities - Featured Image

Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities

This article was originally published on Med Device Online as part of my guest expert series. You ca...
How To Identify, Quantify and Manage Enterprise Risks for Medical Device Companies with Mike Cremeans - Featured Image

How To Identify, Quantify and Manage Enterprise Risks for Medical Device Companies with Mike Cremeans

In episode #9 of the Global Medical Device Podcast we’re joined by Mike Cremeans. Mike is the Vice P...
The Definitive Guide to ISO 14971 Risk Management for Medical Devices - Featured Image

The Definitive Guide to ISO 14971 Risk Management for Medical Devices

The Many Connotations Of Risk In Medtech Development — And The Consequences Of Getting Them Wrong - Featured Image

The Many Connotations Of Risk In Medtech Development — And The Consequences Of Getting Them Wrong

This article was orginal published on Med Device Online. Risk assessment and risk management in the ...
Risk Management from a Regulatory & Product Development Perspective [Podcast] - Featured Image

Risk Management from a Regulatory & Product Development Perspective [Podcast]

  Risk management for medical devices from a regulatory and product development perspective is the t...
3 Tips for Incorporating Risk Management Throughout Medical Device Product Development - Featured Image

3 Tips for Incorporating Risk Management Throughout Medical Device Product Development

Medical device product development and risk management are often treated as entirely separate proces...

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.