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The Ultimate Guide to Preparing Your FDA 510(k) Submission - Featured Image

The Ultimate Guide to Preparing Your FDA 510(k) Submission

What's this guide all about anyways? Feeling a little lost as you start to compile your first 510(k)...
How Phagenesis Is Developing a Treatment for Dysphagia with Rebecca Sheridan - Featured Image

How Phagenesis Is Developing a Treatment for Dysphagia with Rebecca Sheridan

What if regulatory affairs were not only viewed as a necessary burden, but actually help a medical d...
5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare) - Featured Image

5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare)

What should the medical device industry expect in 2017? Great question. I’d like to share some of my...
A Review of the Most Important Medical Device Industry Topics in 2016 - Featured Image

A Review of the Most Important Medical Device Industry Topics in 2016

2016 was a very active and monumental year for the medical device industry. There were several impor...
2016 Medical Device Regulatory Trends Year in Review - Featured Image

2016 Medical Device Regulatory Trends Year in Review

We’re in the last days of 2016, and it’s a good time to look back as we plan for the future. On toda...
Top 10 Most Popular Medical Device Articles of 2016 from greenlight.guru (Plus Top 5 Free Webinars and Podcasts) - Featured Image

Top 10 Most Popular Medical Device Articles of 2016 from greenlight.guru (Plus Top 5 Free Webinars and Podcasts)

Thanks for helping make 2016 another big and exciting year for greenlight.guru filled with growth! W...
Using the Bucket Method for Medical Device Risk Management - Featured Image

Using the Bucket Method for Medical Device Risk Management

Risk management: It’s a topic that needs to be navigated carefully by medical device companies. It’s...
Tips for Success When It Comes to IEC 60601 with Leo Eisner - Featured Image

Tips for Success When It Comes to IEC 60601 with Leo Eisner

  IEC 60601 is a challenge for companies that are developing electronic medical devices. It’s wise t...
The Business Case for Integrated Design Controls - Featured Image

The Business Case for Integrated Design Controls

What role do you believe design controls play in the growth and stability of your company? I suspect...
How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources - Featured Image

How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources

Zebra Medical Technologies is part of a new breed of medical device companies. They understand the r...

The greenlight.guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.