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About the Author

Jesseca Lyons is a Senior Medical Device Guru at Greenlight Guru and a Mechanical Engineer by trade who loves working with cross functional teams, including both engineering and non-engineering disciplines. She’s spent most of her career gathering and defining requirements for new product design and development in the medical device industry. She believes the best part of being an engineer and working at is that she can use her skills to help customers and make a positive impact in their lives.

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Product Development

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

October 20, 2023
What is IQ, OQ, PQ? These are the abbreviations we use in the medical device industry for the three steps of process validation: Installation Qualification (IQ), Operational... Read More
Product Development

Engineering Change Order: Its Role in the Change Management Process

September 14, 2023
Change is just part of life for medical device companies. No device makes it to market without quite a few changes to its design along the way, and even devices already on... Read More
Product Development

CSV vs. CSA: Exploring FDA’s New Software Validation Approach

June 4, 2023
In September of 2022, FDA issued a new draft guidance on software validation: Computer Software Assurance for Production and Quality System Software. Read More
Product Development

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

February 10, 2023
The medical device industry has a lot of acronyms. Read More
Product Development

Beginner's Guide to Design Verification & Design Validation for Medical Devices

February 10, 2023
Design verification and design validation are two essential stages in design controls. It’s easy to confuse the two because they both involve checking an outcome against your... Read More
Regulatory Submission

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

October 4, 2022
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Product Development

Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps

April 25, 2021
The Abbreviated 510(k) pathway is one more tool to add to your tool belt for bringing a new medical device to market. Read More
Product Development

Am I Complying with FDA Medical Device Labeling Requirements?

April 4, 2021
Medical device labeling requirements are a key part of getting your device to market. Read More
Establishing a QMS

Why I Used To Hate Risk Management (And 3 Ways to Change Your Mind Too)

June 30, 2019
I hate Risk Management. There, I said it. And I’m not the only one actually. We’re all thinking it. Risk management is terrible! It’s confusing and lengthy to get through.... Read More

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