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How to Integrate Usability into your Medical Device - Featured Image

How to Integrate Usability into your Medical Device

Medical device usability is a critical, yet confusing component of medical device design, developmen...
[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD) - Featured Image

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

In this modern digital world, did you know that most medical devices are not connected to the Intern...
Greenlight Guru Updates Risk Management Capabilities to Align with ISO 14971:2019, Further Enhances Change Management Capabilities - Featured Image

Greenlight Guru Updates Risk Management Capabilities to Align with ISO 14971:2019, Further Enhances Change Management Capabilities

Medical device quality management system (MDQMS) aligns with latest version of globally recognized r...
The Definitive Guide to ISO 14971 Risk Management for Medical Devices - Featured Image

The Definitive Guide to ISO 14971 Risk Management for Medical Devices

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets) - Featured Image

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)

As leaders of medical device companies, our goal is always to create devices that are safe and effec...
Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device? - Featured Image

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

FDA recently announced its new Safer Technologies Program (STeP), which intends to make medical devi...
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 ...

The Greenlight Guru Medical Device Blog

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

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