Clinical Login Support Contact Sales
Products

More than a Quality Management System: Tools for the entire MedTech Lifecycle.

Learn More

Featured Capabilities:

Document Management Training Management CAPA Management Audit Management Product Development

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

View Product Tour

Accelerate development with integrated design control and risk software.

Learn More

Featured Capabilities:

Design Controls Risk Management Risk Intelligence

Schedule a custom demo of Greenlight Guru Product now.

REQUEST A DEMO

Data collection and management designed for MedTech clinical trials.

Learn More

Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

Get a personalized demo of Greenlight Guru Clinical today.

Request a Demo
Solutions
Why Us
Customers
Partners
Company
Resources
ROI Report Cover

Calculate Your ROI
Pricing
Request a Demo
Request a Demo

Posts by Etienne Nichols

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

View Post
Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
View Post
featured

Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
View Post

Filter All Blog Posts

About the Author

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.

Showing Results for

Product Development

FDA Proposes New Rule to Regulate LDTs as IVDs: Here’s What’s at Stake

Etienne Nichols
October 13, 2023
On October 3, 2023, the Food and Drug Administration (FDA) published a proposed rule seeking to amend FDA’s regulations to bring Laboratory Developed Tests (LDTs) under the... Read More
MedTech Lifecycle Excellence

UDI and EUDAMED: Past, Present and Future State

Etienne Nichols
October 12, 2023
In this episode, we discuss the past, present, and future state of EUDAMED. EUDAMED is the European Database for Medical Devices, and is part of the European Medical Device... Read More
MedTech Lifecycle Excellence

Selecting a Site for Your Clinical Trial

Etienne Nichols
October 5, 2023
In this episode, we discuss how to select a site for a clinical trial. Read More
MedTech Lifecycle Excellence

Moving MedTech Forward - The Past, Present & Future of Greenlight Guru

Etienne Nichols
September 21, 2023
In this riveting episode of the Global Medical Device Podcast, Etienne Nichols brings together the dynamic leaders from Greenlight Guru: David DeRam (internally known as DD)... Read More
MedTech Lifecycle Excellence

From Academia to FDA Clearance (True Quality Roadshow - Boston)

Etienne Nichols
September 14, 2023
In this episode recorded in front of a live audience in Boston, MA, we speak with Christy Sheehy-Bensinger, the CEO & Founder of C-Light Technologies, Inc. about their... Read More
Product Development

5 Tips for Medical Device Registration across Global Markets

Etienne Nichols
September 14, 2023
You have compiled all of the necessary documentation for your regulatory submission, submitted it to the appropriate regulatory body, and received the much-anticipated news... Read More
Establishing a QMS

Greenlight Guru Yet Again Ranked as a Leader in QMS and Medical QMS Categories in G2 Fall 2023 Grid Reports

Etienne Nichols
September 13, 2023
The leaves may be starting to change, but one thing you can count on staying the same is G2 ranking Greenlight Guru as a Leader in both the QMS and Medical QMS Grid® Reports. Read More
Regulatory Submission

Accelerating SaMD Development in a Compliant Agile Way

Etienne Nichols
September 7, 2023
In this episode, we explore the impact of software development methodologies in the medical device industry. Read More
Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

Etienne Nichols
September 1, 2023
Read More

Experience the Guru Edge

Our industry expertise extends beyond our software. Explore our other resources that are helping leading MedTech companies reach success.

Academy

Accelerate your learning and proficiency - both in Greenlight Guru solutions and industry best practices. You’ll be equipped to build key competencies for your teams.

 Elevate Your Education
Community

You're not alone. We created a network of peers to connect with and learn from. At any stage of the product development lifecycle, become part of our community to accelerate your path to excellence.

 Find Your Community
Partner Ecosystem

We have over 200 strategic partnerships with leading consultants in quality, regulatory, testing, design, and clinical.

 Become a Partner
Resources

Do you have a unique problem that needs solving? Or maybe you’re just looking to elevate your expertise. If you're a MedTech professional looking to improve the quality of life for your patients, we have the right resources for you.

 Explore Our Content Hub