Medical Device Quality, Regulatory and Product Development Blog

Ultimate List of Medical Device Incubators and Accelerators (50+)

By Nick Tippmann on January 12, 2018

Medical startups around the United States face many of the same challenges when it comes to achievin...

Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

By Nick Tippmann on January 10, 2018

This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510...

5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)

By Jon Speer on January 8, 2018

There is an old saying that the only thing that is constant in life is change. For the medical devic...

Top 10 Most Popular Greenlight Guru Medical Devices Posts of 2017

By Nick Tippmann on December 25, 2017

Thanks for helping make 2017 another big and exciting year for Greenlight Guru filled with tremendou...

An Overview of What Medical Device Developers Need to Know About Human Factors

By Nick Tippmann on December 20, 2017

The topic of human factors can be confusing: How does it relate to design factors and risk? Why is i...

15 Steps to Getting Approval for IEC 60601-1

By Jon Speer on December 18, 2017

Does your company have approval for IEC 60601-1? If you produce medical electrical equipment (MEE)...

Top 30+ Medical Device Conferences You Should Be Attending in 2018

By Nick Tippmann on December 11, 2017

If you’re looking to land your company's next big deal, keep up on the latest regulatory trends, for...

How to Integrate Complaint Handling and Risk Management

By Jon Speer on December 5, 2017

Did you know that complaint handling continues to be a big reason medical device companies receive 4...

Challenges with Applying Risk Management Throughout the Manufacturing Process

By Nick Tippmann on November 29, 2017

Today we’re going to be taking the topic of risk management to the next level. We are talking to Jim...

How to Streamline the Customer Complaint Handling Process

By Jon Speer on November 27, 2017

It can be quite nerve-wracking the very first time your medical device company receives a complaint ...

13 Steps to Creating a Risk-Based CAPA Process

By Nick Tippmann on November 20, 2017

What does it mean to create a risk-based CAPA process? How should companies go about it?

Common Mistakes That Can Tank Your FDA 510(k) Submission

By Nick Tippmann on November 16, 2017

Do you know the percentage of 510(k)s that are rejected by the FDA the first time? Shockingly, it’s ...

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