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Why SaMD Companies Should be Leveraging Pre-Submissions to FDA - Featured Image

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

Software as a Medical Device (SaMD) is one of the fastest growing segments of the medical device ind...
3 Reasons Why Closed-Loop Traceability is a QMS Must - Featured Image

3 Reasons Why Closed-Loop Traceability is a QMS Must

There is a growing expectation in the medical device industry of manufacturers to demonstrate closed...
Quality Assurance vs. Quality Control in the Medical Device Industry - Featured Image

Quality Assurance vs. Quality Control in the Medical Device Industry

Imagine that your medical device malfunctioned during patient use. Do you know whether quality assur...
519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement - Featured Image

519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement

In the medical device industry, there’s a lot outside of our control. The market shifts. New, innova...
Document Control for Medical Device Companies: The Ultimate Guide - Featured Image

Document Control for Medical Device Companies: The Ultimate Guide

According to the original data findings of our 2020 State of Medical Device Product Development and ...
Unannounced Audits: A Survival Guide for Quality Managers - Featured Image

Unannounced Audits: A Survival Guide for Quality Managers

We’re in an industry that requires preparation. Unlike less regulated industries, there’s an expecta...
5 Tips for Medical Device Registration across Global Markets - Featured Image

5 Tips for Medical Device Registration across Global Markets

You have compiled all of the necessary documentation for your regulatory submission, submitted it to...
Meet a Guru: Tom Rish - Featured Image

Meet a Guru: Tom Rish

What makes Greenlight Guru so unique, beyond its medical device QMS (MDQMS) software? Its Guru edge.
Top 100 Medical Device Acronyms & Terminology You Need to Know - Featured Image

Top 100 Medical Device Acronyms & Terminology You Need to Know

In the medical device industry, knowledge is power. Your knowledge of medical device terminology emp...
How to Build a QMS for a Medical Device - Featured Image

How to Build a QMS for a Medical Device

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task...
How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations - Featured Image

How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations

What is the expected process you should follow for your medical device design planning and controls?
The Beginner's Guide to Design Verification and Design Validation for Medical Devices - Featured Image

The Beginner's Guide to Design Verification and Design Validation for Medical Devices

When your medical device product development project gets to Design Verification and Design Validati...

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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