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Jon Speer

Jon Speer
Jon is the founder and VP of QA/RA at Greenlight Guru (quality management software exclusively for medical device companies) & a medical device guru with nearly 20 years industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to True Quality.

Author's Posts

8 Most Common Mistakes to Avoid with FDA 21 CFR Part 820 - Featured Image

8 Most Common Mistakes to Avoid with FDA 21 CFR Part 820

If you’re a medical device company selling or planning to sell into the US market, you should be fam...
State of Medical Device Product Development and Quality Management Report 2020 - Featured Image

State of Medical Device Product Development and Quality Management Report 2020

Greenlight Guru, the only medical device quality management system (MD QMS) software platform, today...
Definitive Guide to Change Management for Medical Devices - Featured Image

Definitive Guide to Change Management for Medical Devices

7 Tips to Attract Investors and Raise Funds for your Medical Device - Featured Image

7 Tips to Attract Investors and Raise Funds for your Medical Device

Is your medical device company in the midst of raising funds or planning to begin the process? There...
5 Do's and Don'ts when Choosing a QMS Solution for your Medical Device Company - Featured Image

5 Do's and Don'ts when Choosing a QMS Solution for your Medical Device Company

As a medical device manufacturer, your quality management system is the heart of your operations. 
Best Practices for Expediting Your Product Development - Featured Image

Best Practices for Expediting Your Product Development

Speed to market is one of the major challenges for medical device companies. So, how can you expedit...
5 Tips from MedTech Executives on the Value of Quality - Featured Image

5 Tips from MedTech Executives on the Value of Quality

When it comes to making medical devices, quality is key.
Why the FDA Pre-Submission is an Underutilized Tool - Featured Image

Why the FDA Pre-Submission is an Underutilized Tool

“I wish there was a way for the FDA to give me a feedback about my medical device, prior to submissi...
What is a Quality Culture? (and 7 tips for creating one) - Featured Image

What is a Quality Culture? (and 7 tips for creating one)

In the medical device industry, the word quality can mean different things to different people. To s...
6 Most Common Mistakes When Implementing ISO 13485 - Featured Image

6 Most Common Mistakes When Implementing ISO 13485

Companies must establish and maintain a quality management system in order to ensure they are produc...
Everything You Need To Know To Perform Effective Root Cause Analysis - Featured Image

Everything You Need To Know To Perform Effective Root Cause Analysis

Picture this: something goes wrong with a medical device, and a complaint is issued. In a post-marke...
FDA QSIT: Preparing Your Medical Device Company for an Inspection - Featured Image

FDA QSIT: Preparing Your Medical Device Company for an Inspection

Preparing for an FDA QSIT inspection can be a daunting task for medical device manufacturers. Many c...

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