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Greenlight Guru Medical Device Blog

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Meet a Guru: Maryann Mitchell - Featured Image

Meet a Guru: Maryann Mitchell

What makes Greenlight Guru unique and sets it apart from other medical device solutions? It’s Guru e...
5 Biggest Quality Mistakes (And How You Can Avoid Making Them) - Featured Image

5 Biggest Quality Mistakes (And How You Can Avoid Making Them)

At Greenlight Guru, we collectively have hundreds of years of experience in medical device quality m...
Why Storytelling Matters for Medical Device Companies - Featured Image

Why Storytelling Matters for Medical Device Companies

Medical device companies need to tell slightly different versions of their stories depending on the ...
CEO of High-Growth Software Company Places Top 10 in the World in Elite Rowing Competition - Featured Image

CEO of High-Growth Software Company Places Top 10 in the World in Elite Rowing Competition

David DeRam, CEO of Greenlight Guru, credits mindset techniques such as autohypnosis for both rowing...
5 Postmarket Surveillance System Musts for Every EU Manufacturer - Featured Image

5 Postmarket Surveillance System Musts for Every EU Manufacturer

Designing, developing, and getting your medical device approved and onto the market is a huge accomp...
A Breakthrough Device that Aims to Prevent Osteoporosis - Featured Image

A Breakthrough Device that Aims to Prevent Osteoporosis

Is your body becoming more frail? Are you worried about fractures? Do you want to improve your bone ...
3 Things Med Device Startups Must Do When Implementing a QMS - Featured Image

3 Things Med Device Startups Must Do When Implementing a QMS

I often hear early-stage medical device companies say they’re not ready for a quality management sys...
First-In-Class Diagnostics Tool Gets 510(k) Clearance Thanks to Medical Device Success Platform - Featured Image

First-In-Class Diagnostics Tool Gets 510(k) Clearance Thanks to Medical Device Success Platform

Understanding FDA's New Intended Use Rule and its Implications - Featured Image

Understanding FDA's New Intended Use Rule and its Implications

FDA published a final rule, which goes into effect the first of September, to amend its “intended us...
7 Documentation Musts for All Software Device Premarket Submissions - Featured Image

7 Documentation Musts for All Software Device Premarket Submissions

As the prevalence of software in medical devices and software as medical devices (SaMD) has increase...
Medical Device QMS + Guru MedTech Experts: A Winning Combo for Global Market Success - Featured Image

Medical Device QMS + Guru MedTech Experts: A Winning Combo for Global Market Success

Advanced magnetic resonance imaging (MRI) technology has become an important piece of healthcare tha...
3 Life[cycle] Hacks for Integrating Risk Management throughout all Device Phases - Featured Image

3 Life[cycle] Hacks for Integrating Risk Management throughout all Device Phases

Too many companies still treat risk management as a “checkbox” activity.

The Greenlight Guru Medical Device Blog

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

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