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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

Adopting AI in Quality Management: Practical Solutions for the MedTech Industry

Etienne Nichols
March 5, 2024
In MedTech, an increasing number of companies are introducing devices integrated with AI technologies. Read More
MedTech Lifecycle Excellence

Quality Myths & Lessons Learned Part II

Etienne Nichols
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

Etienne Nichols
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

Etienne Nichols
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

Etienne Nichols
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

Etienne Nichols
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

Etienne Nichols
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

Etienne Nichols
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

Etienne Nichols
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

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