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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.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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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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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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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

The Evolving Landscape of AI in MedTech

Etienne Nichols
January 4, 2024
In this insightful episode, Eric Henry and Etienne Nichols delve into the evolving landscape of AI in MedTech, focusing on regulatory compliance and the future of AI in... Read More
MedTech Lifecycle Excellence

Climbing the MedTech Career Ladder - How to Get to the Top

Etienne Nichols
December 21, 2023
In this episode of the Global Medical Device Podcast, we’re joined by Elena Kyria, a talent acquisition specialist and CEO of Elemed. Read More
MedTech Lifecycle Excellence

Considerations for IVD

Etienne Nichols
December 14, 2023
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Carmen Brown, the regulatory and quality affairs manager at Proxima... Read More
MedTech Lifecycle Excellence

Human-Centered Design in Medical Devices

Etienne Nichols
December 7, 2023
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Morven Shearlaw, co-founder of Fearsome, in a thought-provoking discussion... Read More
MedTech Lifecycle Excellence

FDA's eSTAR Program

Etienne Nichols
December 1, 2023
This episode of the Global Medical Device Podcast delves into the world of FDA submissions, specifically focusing on the eSTAR program. Read More
MedTech Lifecycle Excellence

Using AI in MedTech

Etienne Nichols
November 22, 2023
In this episode, we delve into the burgeoning world of artificial intelligence in MedTech. Read More
Establishing a QMS

The Ugly Truth About Managing Design Controls on Spreadsheets

Etienne Nichols
November 20, 2023
At one point in my career, after managing the design controls and risk management documentation, I decided to move on. Read More
MedTech Lifecycle Excellence

Becoming an Advisor to a Medical Device Company

Etienne Nichols
November 16, 2023
In this episode, we delve into the multifaceted aspects of advisory roles within medical device startups. Read More
Establishing a QMS

Enterprise Quality Management Software: What You Need To Know

Etienne Nichols
November 14, 2023
A quality management system (QMS) is simply a formalized system for documents, policies, procedures, and processes that companies in many industries—including MedTech—use to... Read More

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