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Preparing Your Pre-Submission with the Content FDA Wants to See - Featured Image

Preparing Your Pre-Submission with the Content FDA Wants to See

A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can us...
ISO 14971 Risk Management for Medical Devices: The Definitive Guide - Featured Image

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

Understanding the Value of a Medical Device Guru - Featured Image

Understanding the Value of a Medical Device Guru

Have you ever wondered, what does a medical device guru actually do? What role do they play within G...
Top Risk Management Tools in the Medical Device Industry - Featured Image

Top Risk Management Tools in the Medical Device Industry

The role of risk management for medical devices is not just a regulatory expectation, it’s a critica...
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 ...
How to Build Medical Device Usability Testing and Validation into Your Quality System - Featured Image

How to Build Medical Device Usability Testing and Validation into Your Quality System

Medical device usability testing and validation are critical tasks leading up to a medical device’s ...
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 ...
5 Steps to Faster-to-Market, More Profitable Medical Devices - Featured Image

5 Steps to Faster-to-Market, More Profitable Medical Devices

Healthcare provider market demands are such that medical device companies often find themselves in s...
Knowing vs. Doing as Medical Device Professionals - Featured Image

Knowing vs. Doing as Medical Device Professionals

For medical device professionals, there are the “knowers” and the “doers.”
How to Structure your Medical Device Technical File - Featured Image

How to Structure your Medical Device Technical File

The medical device technical file is a must-have document for devices to be sold in the EU marketpla...
Pivoting Operations to Meet PPE Demand during Pandemic - Featured Image

Pivoting Operations to Meet PPE Demand during Pandemic

Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, ar...
What is a Quality Agreement for Medical Devices? - Featured Image

What is a Quality Agreement for Medical Devices?

There’s a good chance you’re not manufacturing your own medical device—contract medical device manuf...

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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