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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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Product Development

3 Tips for Adding Flexibility to Your MedTech Manufacturing Supply Chain

Etienne Nichols
August 25, 2023
Supply chain management is crucial to any MedTech company’s ability to deliver safe, effective, and high-quality devices to their customers. Read More
Product Development

Machine Learning, AI and Risk Management: TIR34971 Explained

Etienne Nichols
August 18, 2023
TIR34971:2023, Application of ISO 14971 to machine learning in artificial intelligence, was published in March 2023. Read More
MedTech Lifecycle Excellence

Regulatory Strategy and the Advantage of Diversity in MedTech

Etienne Nichols
August 17, 2023
In this episode of the Global Medical Device podcast, we discuss the intricate world of medical device regulations, design, and innovation. Read More
Establishing a QMS

Conducting Quality Investigations in Medical Device Manufacturing

Etienne Nichols
August 11, 2023
When a quality event, like a product or process nonconformance, occurs in the manufacturing of medical devices, there’s a chance that the safety and efficacy of any affected... Read More
MedTech Lifecycle Excellence

28 Days To Save The World - True Quality Roadshow

Etienne Nichols
August 10, 2023
During the Houston leg of our True Quality Roadshow series, we had the opportunity to sit down with Dan Purvis, CEO of Velentium and author of "28 Days to Save The World." Read More
MedTech Lifecycle Excellence

3P510k: What Is a 510k 3rd Party Review & What are the Benefits?

Etienne Nichols
August 3, 2023
In today’s episode, Shawnnah Monterrey discusses the 3P510k - which is short for the 510k 3rd Party Review Program. Read More
MedTech Lifecycle Excellence

The Right Way to Start a QMS: When, How, & What

Etienne Nichols
July 28, 2023
Most people in the world of Medical Devices know that they need a Quality Management System, but what is the best way to go about building that QMS, when should you start,... Read More
MedTech Lifecycle Excellence

FDA Guidance on Artificial Intelligence (AI) in Medical Devices

Etienne Nichols
July 20, 2023
In April of 2023, FDA released a draft guidance entitled, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine... Read More
Product Development

How to Improve Detecting, Correcting, and Preventing Nonconformances

Etienne Nichols
July 17, 2023
If you work at a MedTech company, nonconformances are a fact of life. As long as there is still a human element in the development and manufacture of medical devices, there... Read More

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