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FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon? - Featured Image

FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon?

Would things be simpler in the medical device regulatory space if there was global harmonization acr...
Greenlight Guru Announces the Formation of Its New Regulatory Advisory Board - Featured Image

Greenlight Guru Announces the Formation of Its New Regulatory Advisory Board

Leading medical device QMS provider establishes Regulatory Advisory Board comprised of global regula...
Understanding the Value of a Medical Device Guru - Featured Image

Understanding the Value of a Medical Device Guru

Have you ever wondered, what does a medical device guru actually do? What role do they play within G...
Meet a Guru: Etienne Nichols - Featured Image

Meet a Guru: Etienne Nichols

The Guru edge: it's what makes Greenlight Guru so unique and valuable to the medical device companie...
5 Biggest Mistakes to Avoid when Seeking Funding for Your Medical Device - Featured Image

5 Biggest Mistakes to Avoid when Seeking Funding for Your Medical Device

It doesn’t matter how great your medical device concept is—you’ll need some funding to get your idea...
What is 21 CFR 812 - Investigational Device Exemption? - Featured Image

What is 21 CFR 812 - Investigational Device Exemption?

Could your medical device qualify for an investigational device exemption (IDE)?
Meet a Guru: Laura Court - Featured Image

Meet a Guru: Laura Court

What makes Greenlight Guru unique? It’s the Guru edge⁠—a team of medical device professionals with a...
Regulatory Tips & Pointers from a Former FDA Reviewer - Featured Image

Regulatory Tips & Pointers from a Former FDA Reviewer

As some veteran FDA reviewers leave and new ones are hired, knowledge is not always passed on seamle...
Top Risk Management Tools in the Medical Device Industry - Featured Image

Top Risk Management Tools in the Medical Device Industry

The role of risk management for medical devices is not just a regulatory expectation, it’s a critica...
5 Tips to Improve your Medical Equipment Quality Assurance Activities - Featured Image

5 Tips to Improve your Medical Equipment Quality Assurance Activities

You’ve just finished designing what appears to be the perfect medical device. It accomplishes its pr...
Answer these 3 questions before developing Software as a Medical Device - Featured Image

Answer these 3 questions before developing Software as a Medical Device

Health and life science organizations are constantly striving to improve patient centricity and to o...
Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?) - Featured Image

Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?)

Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles...

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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