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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.

Author's Posts

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

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

The Abbreviated 510(k) pathway is one more tool to add to your tool belt for bringing a new medical ...
Am I Complying with FDA Medical Device Labeling Requirements? - Featured Image

Am I Complying with FDA Medical Device Labeling Requirements?

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

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?

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)

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

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

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)

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

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

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

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

When your medical device company makes the decision to go with Greenlight Guru, you might think that...

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