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

Right-sizing your QMS

By Nick Tippmann on August 21, 2019

Is your quality management system (QMS) right-sized to fit with the people, processes and purpose of...

Challenges with Pediatric Medical Devices

By Nick Tippmann on August 14, 2019

Challenges continue with the design and development of pediatric medical devices.

How General Wellness Devices Have Opened a Pandora's Box of Confusion

By Nick Tippmann on July 31, 2019

Do you have a Fitbit, Apple Watch, or other general wellness device to track your activity, monitor ...

Looking at the Sunset of FDA's Alternative Summary Reporting Program

By Nick Tippmann on June 26, 2019

The FDA recently decided to discontinue its alternative summary reporting program due to the allegat...

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...

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