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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 more...
15 Habits of Highly Effective Regulatory Professionals - Featured Image

15 Habits of Highly Effective Regulatory Professionals

Quality and regulatory professionals in the medical device industry have to deal with a lot. In this...
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...
Greenlight Guru Announces Advanced Document Management - Featured Image

Greenlight Guru Announces Advanced Document Management

Functionality enhances security while maintaining visibility and transparency in medical device qual...
How to Embrace Risk for Safer Devices - Featured Image

How to Embrace Risk for Safer Devices

No matter what you are working on, there are risks involved. Product development is complicated.
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?
What you need to know About FDA’s Progressive Programs - Featured Image

What you need to know About FDA’s Progressive Programs

Are you familiar with FDA’s progressive programs for medical device companies? Do you know about Exp...
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.
What Are the Regulatory Expectations for Software as a Medical Device (SaMD)? - Featured Image

What Are the Regulatory Expectations for Software as a Medical Device (SaMD)?

These days, medical devices often include software or are standalone software. So, software as a med...
AI Explainability: What That Means and Why it Matters in Healthcare - Featured Image

AI Explainability: What That Means and Why it Matters in Healthcare

Is AI a topic we should be focused on in the medical device industry?
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?

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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