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Challenging “Conventional Wisdom” in Medtech R and D - Featured Image

Challenging “Conventional Wisdom” in Medtech R and D

  The idea of “research versus development” can be highly controversial and much-debated among medic...
How to Design for Compliance with IEC60601 - Featured Image

How to Design for Compliance with IEC60601

Have you ever designed a medical device that has electrical components? Was it frustrating to go thr...
A Step-by-Step Guide to Preparing Your FDA 510(k) Submission - Featured Image

A Step-by-Step Guide to Preparing Your FDA 510(k) Submission

What's this guide all about anyways? Feeling a little lost as you start to compile your first 510(k)...
FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You? - Featured Image

FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

The FDA announced a new proposal regarding the bundling of device malfunctions when Medical Device R...
A Guide to Bridging User Needs Into Design Requirements - Featured Image

A Guide to Bridging User Needs Into Design Requirements

  “The answers are only as good as the questions we ask!”
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 to Use the Abbreviated FDA 510(k) Pathway to Your Advantage - Featured Image

How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage

Do you know how to use the FDA’s abbreviated 510(k)? Since only 2 percent of 510(k)s have gone the a...
How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X in Two Years - Featured Image

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X in Two Years

  Have you ever wondered what partnering with Greenlight Guru could mean for your business? We have ...
7 Questions About the European MDR Answered - Featured Image

7 Questions About the European MDR Answered

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production...
Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors! - Featured Image

Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors!

If there’s no use risk, then no problem! That's what most directives indicate, however, users are un...
What Medical Device Developers Should Know About Human Factors - Featured Image

What Medical Device Developers Should Know About Human Factors

Human factors can be a topic rife with confusion for medical device developers. What do they mean? W...
Tips for Running Effective Internal Quality Audits - Featured Image

Tips for Running Effective Internal Quality Audits

  How did your last internal quality audit go?

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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