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Bringing Innovation and Quality to the Forefront | Greenlight Guru Acquires CanvasGT - Featured Image

Bringing Innovation and Quality to the Forefront | Greenlight Guru Acquires CanvasGT

Greenlight Guru Acquires CanvasGT to Dramatically Enhance Iterative Design Planning for Medical Devi...
Understanding the Quality Control Process in Medical Device Manufacturing - Featured Image

Understanding the Quality Control Process in Medical Device Manufacturing

The goal of any medical device is to improve the lives of its users.
IQ, OQ, PQ: A Quick Guide to Process Validation - Featured Image

IQ, OQ, PQ: A Quick Guide to Process Validation

In the medical device industry, even one failure in a process can lead to devastating consequences f...
ISO 11135: An Overview of Medical Device Sterilization Using Ethylene Oxide - Featured Image

ISO 11135: An Overview of Medical Device Sterilization Using Ethylene Oxide

Once a medical device has been designed, developed, and manufactured to specifications, it may feel ...
Failure Mode Effects Analysis: What Is It & When Should You Use It? - Featured Image

Failure Mode Effects Analysis: What Is It & When Should You Use It?

Failure mode effects analysis (FMEA) is one of the best-known risk management tools within engineeri...
25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition - Featured Image

25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition

In this article you will find a comprehensive list of the most frequently asked questions from parti...
7 Project Management Tips - Featured Image

7 Project Management Tips

When I began my medical device career, I started as a product development engineer. Part of the role...
Project Management for Product Development of Medical Devices - Featured Image

Project Management for Product Development of Medical Devices

How should you approach project management for medical device product development ? Stop managing yo...
Preparing Your Pre-Submission with the Content FDA Wants to See - Featured Image

Preparing Your Pre-Submission with the Content FDA Wants to See

A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can us...
ISO 14971 Risk Management for Medical Devices: The Definitive Guide - Featured Image

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

Understanding the Value of a Medical Device Guru - Featured Image

Understanding the Value of a Medical Device Guru

Have you ever wondered, what does a medical device guru actually do? What role do they play within G...
Top Risk Management Tools in the Medical Device Industry - Featured Image

Top Risk Management Tools in the Medical Device Industry

The role of risk management for medical devices is not just a regulatory expectation, it’s a critica...

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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