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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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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

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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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Establishing a QMS

15 Questions to Ask QMS Software Vendors in the Medical Device Industry

Etienne Nichols
June 25, 2023
As a medical device company, you are expected to deliver innovative, life-changing medical device(s) while ensuring compliance and achieving true quality. This task bears... Read More
Product Development

How to Develop a Risk-Based Approach to Supplier Management

Etienne Nichols
June 18, 2023
The goal of your MedTech company’s supplier management process should be to ensure a consistent supply of high-quality parts and components that conform to your... Read More
Establishing a QMS

Customers Rank Greenlight Guru Leader in QMS and Medical QMS Software in G2 Grid Reports for Summer 2023

Etienne Nichols
June 18, 2023
We are honored to announce that users have once again selected Greenlight Guru as a leading QMS vendor for the nineteenth consecutive quarter in G2’s Summer 2023 QMS Grid... Read More
MedTech Lifecycle Excellence

The Combination Products Handbook

Etienne Nichols
June 15, 2023
Combination products are a difficult niche because they combine so many different elements. However, today’s guest literally wrote the book on the topic, and she’s joining... Read More
Establishing a QMS

15 Reasons Why Medical Device Companies Choose Greenlight Guru

Etienne Nichols
June 12, 2023
MedTech companies are not just companies—they’re innovators building the medical devices that are saving and improving our quality of life. But, bringing life-changing... Read More
Product Development

How to Manage Complex Downstream Design Changes to Your Medical Device

Etienne Nichols
June 11, 2023
It would be nice if every device your company ever produced got to remain on the market for decades, completely unchanged. Read More
Product Development

Purpose-Built QMS vs General-Purpose QMS: What You Can Expect From Each

Etienne Nichols
June 8, 2023
Just like the tools at your local hardware store, quality management software comes in many shapes and sizes. Read More
MedTech Lifecycle Excellence

Leaning into Lean Documentation

Etienne Nichols
June 7, 2023
What is lean documentation and how can you achieve it? Our guest on today’s live podcast is an expert on quality management systems, audits, and most importantly for today’s... Read More
MedTech Lifecycle Excellence

Cybersecurity and the Future of MedTech

Etienne Nichols
June 2, 2023
The "Consolidated Appropriations Act of 2023" (more commonly referred to as the Omnibus Act) was passed and signed into law on December 29th, 2022. This amendment to the Food... Read More

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