Greenlight Guru Medical Device Blog

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The Bleeding Edge: Lessons Learned for the Medical Device Industry - Featured Image

The Bleeding Edge: Lessons Learned for the Medical Device Industry

Sometimes, do things make you go, “Hhhmmmm…” Jon Speer recently watched a documentary about the medi...
AI Explainability: What that Means and Why it Matters in the Medical Device Industry - Featured Image

AI Explainability: What that Means and Why it Matters in the Medical Device Industry

Is artificial intelligence (AI) a topic that should be focused on in the medical device industry?
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.
How Human Factors Impact Your Medical Device - Featured Image

How Human Factors Impact Your Medical Device

Human factors can be a tricky topic that creates confusion, especially when it comes to medical devi...
Top 100 Medical Device Companies - Featured Image

Top 100 Medical Device Companies

Have you ever wondered about the biggest medical device companies in the world? Maybe you're looking...
How to Think About Quality and Regulatory as Your Company Scales - Featured Image

How to Think About Quality and Regulatory as Your Company Scales

As companies transition from being a start-up or small company to a more established business and br...
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...

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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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