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Jesseca Lyons

Jesseca Lyons
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.
Connect with me:
https://www.linkedin.com/in/jessecalyons jesseca.lyons@greenlight.guru http://www.greenlight.guru/

Author's Posts

Am I Complying with FDA Medical Device Labeling Requirements? - Featured Image

Am I Complying with FDA Medical Device Labeling Requirements?

By Jesseca Lyons on April 4, 2021
Medical device labeling requirements are a key part of getting your device to market.
The Beginner's Guide to Design Verification and Design Validation for Medical Devices - Featured Image

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

By Jesseca Lyons on June 12, 2020
When your medical device product development project gets to Design Verification and Design Validati...
Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference? - Featured Image

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

By Jesseca Lyons on May 29, 2020
The medical device industry has a lot of acronyms. 
Why I Used To Hate Risk Management (And 3 Ways to Change Your Mind Too) - Featured Image

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

By Jesseca Lyons on June 30, 2019
I hate Risk Management. There, I said it. And I’m not the only one actually. We’re all thinking it. ...
FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours - Featured Image

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

By Jesseca Lyons on July 20, 2018
What's this guide all about anyways? Feeling a little lost as you start to compile your first 510(k)...
Fundamentals of Supplier Management for Medical Device Companies - Featured Image

Fundamentals of Supplier Management for Medical Device Companies

By Jesseca Lyons on March 19, 2017
As a manufacturer of medical devices, it is your responsibility to be on top of the entire system th...
Why Use ISO 14971 vs. FMEA (Template Included) - Featured Image

Why Use ISO 14971 vs. FMEA (Template Included)

By Jesseca Lyons on August 1, 2016
This may be stating the obvious, but engineers are generally very analytical. One of the areas where...
3 Common Misconceptions About Medical Device Packaging - Featured Image

3 Common Misconceptions About Medical Device Packaging

By Jesseca Lyons on July 18, 2016
If you asked people what comes to mind when you say designing a medical device, you’re likely going ...
5 Places Paper Might Be Hiding in Your Medical Device Company - Featured Image

5 Places Paper Might Be Hiding in Your Medical Device Company

By Jesseca Lyons on July 11, 2016
A few weeks ago you left a big pile of paperwork (also known as your Document Change Order (DCO/ECO)...
3 Common Misconceptions About Medical Device Labeling - Featured Image

3 Common Misconceptions About Medical Device Labeling

By Jesseca Lyons on June 29, 2016
When you first start designing and developing a new medical device, you spend a bunch of time learni...
What It Means to Join the Greenlight Guru Family - Featured Image

What It Means to Join the Greenlight Guru Family

By Jesseca Lyons on June 27, 2016
When your medical device company makes the decision to go with Greenlight Guru, you might think that...
5 Medical Device Project Management Tips That Will Help You Complete Your Project On Time - Featured Image

5 Medical Device Project Management Tips That Will Help You Complete Your Project On Time

By Jesseca Lyons on June 13, 2016
If you’re an engineer at a small medical device company, chances are, at some point, you’re going to...

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