Greenlight Guru Medical Device Blog

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Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors! - Featured Image

Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors!

If there’s no use risk, then no problem! That's what most directives indicate, however, users are un...
The Ultimate Guide To Design Controls For Medical Device Companies - Featured Image

The Ultimate Guide To Design Controls For Medical Device Companies

Understanding the 5 Phases of Medical Device Development - Featured Image

Understanding the 5 Phases of Medical Device Development

Do you have a medical device to launch? Well I have good news for you and I have bad news for you.
Top 10 Most Popular Greenlight Guru Medical Devices Posts of 2017 - Featured Image

Top 10 Most Popular Greenlight Guru Medical Devices Posts of 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 - Featured Image

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

If you’re looking to land your company's next big deal, keep up on the latest regulatory trends, for...
How Process Excellence Leads to Product Excellence - Featured Image

How Process Excellence Leads to Product Excellence

Today, we are talking to Mike Fisher, who is the director of product development at the Global Cente...
13 Common Pitfalls to Avoid During Medical Device Product Development - Featured Image

13 Common Pitfalls to Avoid During Medical Device Product Development

  Are you falling into some of the common traps that surround medical device product development?
Technical File vs. 510(k) vs. Design History File: What Medical Device Developers Should Know - Featured Image

Technical File vs. 510(k) vs. Design History File: What Medical Device Developers Should Know

Sometimes it feels like you need to know an entirely new language to work in the medical device fiel...
Best Practices for Expediting Your Medical Device Product Development - Featured Image

Best Practices for Expediting Your Medical Device Product Development

Speed to market is one of the major challenges for medical device companies; how can you expedite th...
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...
Why Use ISO 14971 vs. FMEA (Template Included) - Featured Image

Why Use ISO 14971 vs. FMEA (Template Included)

This may be stating the obvious, but engineers are generally very analytical. One of the areas where...
Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): Understanding the Differences and What Documents to Include - Featured Image

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): Understanding the Differences and What Documents to Include

DHF. DMR. DHR. It’s bad enough that medical device product development has a whole slew of new terms...

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

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