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

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Accelerate development with integrated design control and risk software.

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Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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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.
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Chris Rush
April 12, 2024

Ultimate Guide to Clinical Data Management in MedTech

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Establishing a QMS

FDA Publishes Final Rule on QMSR

Etienne Nichols
February 2, 2024
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Establishing a QMS

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

Laura Maher
January 3, 2024
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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.

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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
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Establishing a QMS

What is a Predetermined Change Control Plan (PCCP) and Who Needs One?

Etienne Nichols
September 1, 2023
In April 2023, FDA published a new draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning... Read More
Regulatory Submission

MedTech Funding and Preparing for Due Diligence

Etienne Nichols
August 31, 2023
Join guest Devon Campbell as we discuss MedTech funding in this episode of the Global Medical Device Podcast. He unveils startup red flags, from data integrity to product... Read More
Regulatory Submission

Exploring Breakthrough Device Designation

Etienne Nichols
August 25, 2023
In this episode of the Global Medical Device Podcast, Etienne Nichols and Ellie Reynolds explore FDA's Breakthrough Device designation. Read More

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