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Greenlight Guru Medical Device Blog

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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.
Meet a Guru: Ryan Behringer - Featured Image

Meet a Guru: Ryan Behringer

Guru Edge. It's what makes Greenlight Guru so unique and particularly valuable to medical device com...
How New Training Partnership is Advancing Medical Device Knowledge & Professional Development - Featured Image

How New Training Partnership is Advancing Medical Device Knowledge & Professional Development

Hungry for medical device industry knowledge? Greenlight Guru has you covered — now, medical device ...
Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020 - Featured Image

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

What did FDA report as the most-cited issues during medical device inspections for the fiscal year o...
ISO 14971 Risk Management for Medical Devices: The Definitive Guide - Featured Image

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

5 Tips to Improve your Medical Equipment Quality Assurance Activities - Featured Image

5 Tips to Improve your Medical Equipment Quality Assurance Activities

You’ve just finished designing what appears to be the perfect medical device. It accomplishes its pr...
Quality Management for IVD Devices vs Medical Devices - Featured Image

Quality Management for IVD Devices vs Medical Devices

How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD...
What is a Traceability Matrix and How Do I Create One for My Medical Device? - Featured Image

What is a Traceability Matrix and How Do I Create One for My Medical Device?

You’ve probably heard a traceability matrix is something you need as part of your medical device QMS...
5 Actionable Lessons Learned from the RADx Initiative by NIH - Featured Image

5 Actionable Lessons Learned from the RADx Initiative by NIH

Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Hea...
How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist) - Featured Image

How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)

So you need to make a change to your medical device, what now?
Are you Spending Enough Time Defining and Managing Requirements for your Medical Device? - Featured Image

Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

Some sources claim that one-third of your product development project should be spent on defining go...
23 Must-haves for your Product Requirements Document (Free Checklist + Guide) - Featured Image

23 Must-haves for your Product Requirements Document (Free Checklist + Guide)

With the rapidly accelerating pace of innovation in the medical device arena, the procedures and pra...

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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