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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.

MedTech Lifecycle Excellence

Managing Risk in Clinical Investigations

Etienne Nichols
April 23, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Helene Quie, an expert in medical device regulations and clinical investigations. Read More
MedTech Lifecycle Excellence

FDA’s PMA Supplements and Amendments: When and How to Use Each

Etienne Nichols
April 19, 2024
The regulatory pathway for getting a Class III medical device to market in the US is known as Premarket Approval (PMA). Given that Class III devices pose the highest risk to... Read More
MedTech Lifecycle Excellence

Speaking the Language of IVD

Etienne Nichols
April 18, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the intricate world of in vitro diagnostics (IVDs) with Christie Hughes, a principal... Read More
MedTech Lifecycle Excellence

Is It Possible to "Buy" a QMS?

Etienne Nichols
April 12, 2024
In this episode of the Global Medical Device Podcast, Etienne Nichols engages with Sara Adams to discuss Quality Management Systems (QMS) in the medical device industry. Read More
MedTech Lifecycle Excellence

What is a Class III Medical Device in the US?

Etienne Nichols
April 8, 2024
In the US, the Food and Drug Administration (FDA) is the federal agency tasked with regulating the medical device market and ensuring the safety and effectiveness of all... Read More
MedTech Lifecycle Excellence

Project Management in MedTech

Etienne Nichols
April 4, 2024
This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management... Read More
Regulatory Submission

Step-by-Step Guide to FDA PMA Submissions for Class III Medical Devices

Etienne Nichols
April 2, 2024
The premarket approval (PMA) process is the method FDA uses to evaluate the safety and effectiveness of Class III medical devices before they can be placed on the US market. Read More
MedTech Lifecycle Excellence

FDA's Voluntary Improvement Program

Etienne Nichols
March 21, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kim Kaplan from ISACA at the MD&M West trade show in Anaheim, California, to discuss... Read More
MedTech Lifecycle Excellence

The State of UDI Across the World

Etienne Nichols
March 7, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Gary Saner, a seasoned expert in medical device Unique Device Identification (UDI) and... Read More

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