Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

Is Your Medical Device Company CAPA Happy?

By Nick Tippmann on June 12, 2019

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

By Nick Tippmann on May 9, 2019

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

By Nick Tippmann on April 11, 2019

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

By Nick Tippmann on March 27, 2019

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

By Nick Tippmann on March 8, 2019

FDA has been busy working on guidance documents, including Nonbinding Feedback After Certain FDA Ins...

Who Should Own Your QMS?

By Nick Tippmann on February 21, 2019

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

By Nick Tippmann on January 25, 2019

Regulatory compliance is critically important. However, some think product liability is just as impo...

Explaining the Significance of Voluntary Consensus Standards

By Nick Tippmann on January 2, 2019

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?

By Nick Tippmann on December 5, 2018

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

By Nick Tippmann on November 28, 2018

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

By Nick Tippmann on November 21, 2018

Are you confused by regulatory terminology? Clearance. Approval. Granted. Do these terms matter or m...

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

By Nick Tippmann on November 7, 2018

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

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