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7 Tips to Attract Investors and Raise Funds for your Medical Device - Featured Image

7 Tips to Attract Investors and Raise Funds for your Medical Device

Is your medical device company in the midst of raising funds or planning to begin the process? There...
Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents - Featured Image

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How...
Why I Used To Hate Risk Management (And 3 Ways to Change Your Mind Too) - Featured Image

Why I Used To Hate Risk Management (And 3 Ways to Change Your Mind Too)

I hate Risk Management. There, I said it. And I’m not the only one actually. We’re all thinking it. ...
10 Essentials for Writing a Clear Product Requirements Document [Guide+Checklist] - Featured Image

10 Essentials for Writing a Clear Product Requirements Document [Guide+Checklist]

We distilled the insights from our research into this one guide + checklist that we hope will help a...
5 Most Common Mistakes Made When Implementing ISO 14971 - Featured Image

5 Most Common Mistakes Made When Implementing ISO 14971

ISO 14971 is a descriptive regulatory standard that provides guidance for how to apply risk manageme...
Greenlight Guru In the Classroom: A University's Real-world Approach - Featured Image

Greenlight Guru In the Classroom: A University's Real-world Approach

Greenlight Guru continues to bridge the gap in biomedical engineering education by helping students ...
Improving the Colon Cancer Screening Experience - Featured Image

Improving the Colon Cancer Screening Experience

Preparation for a colonoscopy is not a pleasant or positive experience. From laxatives to the invasi...
Qualifying Your Suppliers Using a Risk-based Approach - Featured Image

Qualifying Your Suppliers Using a Risk-based Approach

This notion of risk-based processes within quality systems is something that has become part of our ...
5 Myths Engineers Believe About Quality (and what is really true) - Featured Image

5 Myths Engineers Believe About Quality (and what is really true)

A well run medical device company is cross-functional in nature. Engineering, quality, regulatory, m...
How to Embrace Risk for Safer Devices - Featured Image

How to Embrace Risk for Safer Devices

No matter what you are working on, there are risks involved. Product development is complicated.
Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1) - Featured Image

Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1)

The ISO Technical Committee TC 210 Joint Working Group 1 (JWG1) is a committee that reports to not o...
7 Problems with a Paper-Based Design History File (And How to Avoid Them) - Featured Image

7 Problems with a Paper-Based Design History File (And How to Avoid Them)

If you’re using a paper-based system to manage your design history file (DHF), it can raise several ...

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

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