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

Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device?

By Wade Schroeder on February 21, 2021

If your medical device falls under premarket submission criteria, there are three types of 510(k) th...

Change Management Process Explained in 6 Easy Steps (+ free template)

By Sara Adams on January 19, 2021

In Prosci’s research, participants were six times more likely to meet project goals by following an ...

Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

By Nick Tippmann on December 23, 2020

Are you prepared for the aftermath of the pandemic’s impact on the medical device industry? It may b...

How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

By Nick Tippmann on December 9, 2020

Still seeking guidance to stay in the know when it comes to new and updated FDA requirements related...

Positive and Negative Impacts of EUA on the Medical Device Industry

By Nick Tippmann on November 11, 2020

As the COVID-19 global pandemic continues, emergency use authorization (EUA) has become a highly uti...

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

By Nick Tippmann on September 2, 2020

What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Specia...

Protecting the Intellectual Property of your Medical Device Technology

By Nick Tippmann on July 22, 2020

Should you have patent protection for your medical device technology? Should you keep your secret sa...

Top 100 Medical Device Acronyms & Terminology You Need to Know

By Jon Speer on July 19, 2020

In the medical device industry, knowledge is power. Your knowledge of medical device terminology emp...

How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations

By Jon Speer on June 28, 2020

What is the expected process you should follow for your medical device design planning and controls?

What is Regulatory Due Diligence for Medical Devices?

By Nick Tippmann on June 24, 2020

What is regulatory due diligence? Why does it matter, and how does it differ from other regulatory s...

Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

By Nick Tippmann on June 3, 2020

Most of us have read about, observed, participated in, and spoke with healthcare providers and medic...

510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

By Nick Tippmann on May 6, 2020

What does the 510(k) process involve? How should medical device companies know if this is the right ...

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