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Establishing a QMS

Understanding ISO 14971 Medical Device Risk Management

May 11, 2023
Medical device companies MUST have established risk management processes that comply with ISO 14971. Read More
Establishing a QMS

5 Dos and Don'ts when Choosing a QMS Solution for Your Medical Device Company

May 10, 2023
As a medical device manufacturer, your quality management system (QMS) is the heart of your operations. Read More
Product Development

Planning Your Medical Device Global Market Regulatory Strategy

May 5, 2023
A regulatory strategy is more than just picking a pathway to market. It’s an in-depth process by which you choose the best markets and pathways not only for your device, but... Read More
Product Development

3 Things to Love about Internal Audits

April 28, 2023
I have a confession to make—I love audits. I mean, I really love audits. Read More
Product Development

4 Advantages of an eQMS Over a Paper-Based QMS

April 21, 2023
One of the biggest factors that determines a medical device company’s success is how effectively they manage quality processes. Read More
Establishing a QMS

How To Avoid a Failed QMS Implementation

April 16, 2023
No one implements a new QMS just for fun. Read More
Establishing a QMS

5 Steps for Getting your CE Marking with EU MDR Requirements

April 14, 2023
It has long been thought that the quickest path to market for medical device manufacturers is to access the European market by obtaining a CE marking instead of going through... Read More
Establishing a QMS

2023 Greenlight Guru True Quality Roadshow: Houston Recap

April 12, 2023
Thank you, Houston! The 2023 True Quality Roadshow got off to an exciting start on March 9th, as Greenlight Guru, along with sponsors Velentium and Rook Quality Systems,... Read More
Product Development

Can dFMEA and ISO 14971 Co-Exist in Medical Device Risk Management?

April 9, 2023
Risk management is a notoriously complex subject—one that many people (including yours truly) have strong feelings about. Read More

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