Medical Device Quality, Regulatory and Product Development Blog

Meet a Guru: Maryann Mitchell

By Nick Tippmann on September 1, 2021

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)

By Sara Adams on August 29, 2021

At Greenlight Guru, we collectively have hundreds of years of experience in medical device quality m...

Why Storytelling Matters for Medical Device Companies

By Nick Tippmann on August 25, 2021

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

By Nick Tippmann on August 24, 2021

David DeRam, CEO of Greenlight Guru, credits mindset techniques such as autohypnosis for both rowing...

5 Postmarket Surveillance System Musts for Every EU Manufacturer

By Sara Adams on August 22, 2021

Designing, developing, and getting your medical device approved and onto the market is a huge accomp...

A Breakthrough Device that Aims to Prevent Osteoporosis

By Nick Tippmann on August 18, 2021

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

By Taylor Brown on August 16, 2021

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

By Nick Tippmann on August 13, 2021

Understanding FDA's New Intended Use Rule and its Implications

By Nick Tippmann on August 11, 2021

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

By Wade Schroeder on August 8, 2021

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

By Nick Tippmann on August 6, 2021

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

By Etienne Nichols on August 1, 2021

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

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