Greenlight Guru Medical Device Blog

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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)?

  In today’s highly connected world, medical devices often include state-of-the-art software, or, th...
What You Need to Know About the FDA CDRH Experimental Learning Program - Featured Image

What You Need to Know About the FDA CDRH Experimental Learning Program

Medical device standards seem to change and evolve all the time. Is it impossible to keep up with th...
The Importance of Good Document Management (And How To Do It) - Featured Image

The Importance of Good Document Management (And How To Do It)

The long-term success of medical device companies depends on the strength of their foundation. Good ...
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...
15 HABITS OF HIGH EFFECTIVE QUALITY AND REGULATORY PROFESSIONALS - Featured Image

15 HABITS OF HIGH EFFECTIVE QUALITY AND 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. Th...
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...

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