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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 greenlight.guru is that she can use her skills to help customers and make a positive impact in their lives.

Product Development

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

October 7, 2022
The medical device industry has a lot of acronyms.  Read More
Regulatory Submission

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

October 4, 2022
Read More
Product Development

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

December 12, 2021
In the medical device industry, even one failure in a process can lead to devastating consequences for patients. Devices need to work exactly as they’re supposed to, every... Read More
Product Development

Engineering Change Order: The Role it Plays in the Change Management Process

November 21, 2021
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

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
Product Development

The Beginner's Guide to Design Verification and Design Validation for Medical Devices

June 12, 2020
When your medical device product development project gets to Design Verification and Design Validation, do you feel like it's almost there? 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
Product Development

Fundamentals of Supplier Management for Medical Device Companies

March 19, 2017
As a manufacturer of medical devices, it is your responsibility to be on top of the entire system that sees your product go from the idea stage to when it is available for... Read More

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