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

Helping to Prepare Biomedical Engineers Entering the Workforce

By Nick Tippmann on April 24, 2018

Students offer hope for our future. They will be developing products that can save our lives, or at ...

Competitive Regulatory Strategy vs. Regular Regulatory Strategy

By Jon Speer on April 23, 2018

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

By Rod Beuzeval on January 30, 2018

One thing that seems to be constant in the global medical device industry is change.

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...

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 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 ...

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 ...

What is Software as a Medical Device (SaMD)?

By Jon Speer on November 13, 2017

Medical devices are a big business covering a wide range of modalities and applications. To ensure t...

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

By Nick Tippmann on November 8, 2017

The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draf...

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

By Jon Speer on October 27, 2017

What Is This CAPA Guide About? As an experienced medical device professional who has worked with doz...

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