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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

Quality Myths & Lessons Learned Part II

February 22, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the world of medical device quality and reliability with expert guest Kevin Becker. Read More
MedTech Lifecycle Excellence

Mastering the Pitch: MedTech Innovations from Concept to Market

February 20, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols dives into the art of pitching to medical device investors with Blythe Karow, COO at Neurogeneces. Read More
MedTech Lifecycle Excellence

Becoming a MedTech Regulatory Affairs Professional

February 7, 2024
In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory... Read More
Establishing a QMS

FDA Publishes Final Rule on QMSR

February 2, 2024
On January 31st, 2024, FDA issued their final rule amending the Quality System Regulation (QSR) to better align with ISO 13485:2016, the international standard for quality... Read More
MedTech Lifecycle Excellence

Calculating Nonconformance Costs in the MedTech Industry

February 2, 2024
In the MedTech industry, nonconformance costs are about more than just your company’s bottom line. Read More
MedTech Lifecycle Excellence

How Artificial Intelligence is Impacting the MedTech Industry

January 30, 2024
In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable... Read More
MedTech Lifecycle Excellence

Fundamentals of Quality & Regulatory

January 18, 2024
In this episode, we delve into the complexities and essentials of quality and regulatory roles in the medical device industry. Read More
MedTech Lifecycle Excellence

The State of AI & Clinical Investigations

January 11, 2024
In a today's conversation on the Global Medical Device Podcast, host Etienne Nichols engages with Dr. Maria Nyakern on the burgeoning integration of AI in medical devices. Read More
MedTech Lifecycle Excellence

The Evolving Landscape of AI in MedTech

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

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