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About the Author

Jon Speer is a medical device expert with over 20 years of 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.

Establishing a QMS

CAPA Process: Step-by-Step Instructions [+ Free Infographic]

November 3, 2023
The CAPA process is a frequent topic of discussion here at Greenlight Guru, mainly because it’s still such a big issue for medical device companies. Year after year, CAPA... Read More
Establishing a QMS

Ultimate Guide to ISO 13485 for Medical Devices QMS

October 2, 2023
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Product Development

The Ultimate Guide To Design Controls For Medical Device Companies

March 17, 2023
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Product Development

Top Risk Management Tools in the Medical Device Industry

February 3, 2023
The role of risk management for medical devices is not just a regulatory expectation, it’s a critical part of designing, developing, and manufacturing safe and effective... Read More
Establishing a QMS

Tips for Structuring Your Internal Audit Program (and Mistakes to Avoid)

January 1, 2023
After a refreshing holiday break, there’s one question you need to ask yourself as you head into the new year: Do we have a plan in place for internal auditing this year? Read More
Product Development

Design Controls Need to Start With User Needs

December 19, 2022
In the FDA’s classic design control waterfall diagram, the box at the left-hand top of the waterfall is labeled “user needs.” Read More
Establishing a QMS

How to Switch to eQMS Software When You're Just Using Paper

December 5, 2022
How reliable is your paper-based quality management system? This situation plays out in medical device companies everywhere: Read More
Product Development

The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

December 2, 2022
“Intended use” and “indications for use” are two of the easiest terms to confuse in the medical device industry. They’re often used interchangeably, not only because they... Read More
Establishing a QMS

What You Need to Know About Risk Management and Using Post-Market Data

October 11, 2022
The aim for any medical device company is always to ensure that the devices they make are safe and effective. Read More

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