Medical Device Quality, Regulatory and Product Development Blog

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

By Jon Speer on May 28, 2021

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

By Nick Tippmann on May 27, 2021

Leading medical device QMS provider establishes Regulatory Advisory Board comprised of global regula...

Understanding the Value of a Medical Device Guru

By Nick Tippmann on May 26, 2021

Have you ever wondered, what does a medical device guru actually do? What role do they play within G...

Meet a Guru: Etienne Nichols

By Nick Tippmann on May 24, 2021

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

By Tom Rish on May 23, 2021

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?

By Laura Court on May 21, 2021

Could your medical device qualify for an investigational device exemption (IDE)?

Meet a Guru: Laura Court

By Nick Tippmann on May 19, 2021

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

By Nick Tippmann on May 17, 2021

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

By Jon Speer on May 16, 2021

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

By Sara Adams on May 14, 2021

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

By PA Consulting on May 13, 2021

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?)

By Nick Tippmann on May 12, 2021

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

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