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What it Means to be Focused on Quality vs. Compliance - Featured Image

What it Means to be Focused on Quality vs. Compliance

  Would you describe your company as quality focused?
Why the FDA Case for Quality Matters - Featured Image

Why the FDA Case for Quality Matters

  When I first learned about the FDA’s Case for Quality initiative, I immediately wanted to learn mo...
21 CFR Part 11: A Complete Guide - Featured Image

21 CFR Part 11: A Complete Guide

Medical device companies that wish to sell their devices in the US and EU must implement a quality m...
Scaling Regulatory and Quality with Your Company - Featured Image

Scaling Regulatory and Quality with Your Company

    Have you thought about your systems and processes related to regulatory and quality standards?
FDA Case for Quality Program: What, Why and How? - Featured Image

FDA Case for Quality Program: What, Why and How?

We recently launched a webinar series alongside the FDA, looking at its Case for Quality Program. Th...
Why Paper-Based Quality Management Systems are No Longer an Option - Featured Image

Why Paper-Based Quality Management Systems are No Longer an Option

  It’s time to face facts: a paper-based quality management system is no longer an option.
Why There is a Need for Multi-Level Design Controls - Featured Image

Why There is a Need for Multi-Level Design Controls

We’ve added an exciting new update to our platform recently. The ability to manage multi-level desig...
How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification - Featured Image

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

We have many different types of companies using Greenlight Guru to help them create a compliant qual...
Creating an Effective Quality Culture that Benefits Your Patients - Featured Image

Creating an Effective Quality Culture that Benefits Your Patients

  We all want medical devices that improve the quality of life for patients, right?
FDA Warning Letters and Form 483 Observations - What’s the Difference? - Featured Image

FDA Warning Letters and Form 483 Observations - What’s the Difference?

If you’re a medical device company manufacturing Class II or Class III devices, you can expect to ha...
Competitive Regulatory Strategy vs. Regular Regulatory Strategy - Featured Image

Competitive Regulatory Strategy vs. Regular Regulatory Strategy

Every medical device developer would like to take the fastest path to market, right? Sometimes the k...
Timeline to ISO 13485:2016 (And Why You Need to Act Today) - Featured Image

Timeline to ISO 13485:2016 (And Why You Need to Act Today)

To be blunt, if your company has put off doing anything about ISO 13485:2016, you need to act immedi...

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

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