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3 FAQ about CE Marking Medical Device Manufacturers Want to Know - Featured Image

3 FAQ about CE Marking Medical Device Manufacturers Want to Know

If you take a close look at many of the objects you use each day—keyboards, monitors, headphones, an...
Creating a Quality Manual That Complies with ISO 13485 - Featured Image

Creating a Quality Manual That Complies with ISO 13485

An excellent quality management system (QMS) is one of the keys to bringing a safe and effective med...
How to Execute a Successful Product Launch - Featured Image

How to Execute a Successful Product Launch

Bringing a medical device to market can take anywhere from three to seven years, on average. The des...
Debunking 4 Commonly Held Design Control Myths - Featured Image

Debunking 4 Commonly Held Design Control Myths

The design control struggle is real.What is the struggle, you ask? Design controls are not being use...
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?
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

Building your Brand as a Medical Device Professional - Featured Image

Building your Brand as a Medical Device Professional

Have you ever had to “sell” your brand to someone? To do this effectively, you must master the art o...
Meet a Guru: Etienne Nichols - Featured Image

Meet a Guru: Etienne Nichols

The Guru edge: it's what makes Greenlight Guru so unique and valuable to the medical device companie...
Meet a Guru: Laura Court - Featured Image

Meet a Guru: Laura Court

What makes Greenlight Guru unique? It’s the Guru edge⁠—a team of medical device professionals with a...
Answer these 3 questions before developing Software as a Medical Device - Featured Image

Answer these 3 questions before developing Software as a Medical Device

Health and life science organizations are constantly striving to improve patient centricity and to o...
Three Tips for Designing At-Home Monitoring Devices that Deliver Actionable Information - Featured Image

Three Tips for Designing At-Home Monitoring Devices that Deliver Actionable Information

We’re all seeing it in real time: Healthcare is increasingly shifting from clinical settings to our ...
Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps - Featured Image

Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps

The Abbreviated 510(k) pathway is one more tool to add to your tool belt for bringing a new medical ...

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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