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Is Your Medical Device Company CAPA Happy? - Featured Image

Is Your Medical Device Company CAPA Happy?

The medical device industry could be more proactive than reactive when managing systemic issues. We’...
How to Make De Novo a Viable Option for your Medical Device - Featured Image

How to Make De Novo a Viable Option for your Medical Device

Is de novo a realistic regulatory pathway? Or, the “kiss of death” for your product? No, to de novo?...
Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices - Featured Image

Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices

It seems like every time you turn on the TV, there’s commercials, movies, and shows that highlight t...
Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway - Featured Image

Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway

FDA recently released a new guidance document titled, Safety and Performance Based Pathway, which pe...
Nonbinding Feedback is a New Guidance You Should Know About - Featured Image

Nonbinding Feedback is a New Guidance You Should Know About

FDA has been busy working on guidance documents, including Nonbinding Feedback After Certain FDA Ins...
Who Should Own Your QMS? - Featured Image

Who Should Own Your QMS?

Does your medical device company prefer to outsource the responsibility of its quality management sy...
Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies - Featured Image

Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies

Regulatory compliance is critically important. However, some think product liability is just as impo...
Explaining the Significance of Voluntary Consensus Standards - Featured Image

Explaining the Significance of Voluntary Consensus Standards

What are Voluntary Consensus Standards? Why should you care about them? What role do they play in yo...
FDA Plans to Modernize 510(k) - Is the Sky Falling? - Featured Image

FDA Plans to Modernize 510(k) - Is the Sky Falling?

Have you heard the news? FDA caused quite a stir when it recently announced transformative changes t...
Understanding the Blurred Lines Between Consumer Tech and MedTech - Featured Image

Understanding the Blurred Lines Between Consumer Tech and MedTech

Did you know that the Apple Watch was recently granted de novo classification requests by the FDA? P...
Understanding The Differences Between Clearance vs Approval vs Granted - Featured Image

Understanding The Differences Between Clearance vs Approval vs Granted

Are you confused by regulatory terminology? Clearance. Approval. Granted.
The New Special 510(k): What You Need To Know - Featured Image

The New Special 510(k): What You Need To Know

Have you heard the recent buzz about the FDA’s supposed new Special 510(k) Pilot Program? Is it real...

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