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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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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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Regulatory Submission

Recent FDA Draft Guidances

Etienne Nichols
November 9, 2023
In this episode, we dissect the evolving landscape of FDA medical device regulations with regulatory expert Mike Drues. Read More
Regulatory Submission

Planning an FDA Submission

Etienne Nichols
November 2, 2023
In this episode, Etienne Nichols and Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dive deep into the... Read More
Establishing a QMS

Benefits of Switching from MasterControl to Greenlight Guru

Etienne Nichols
November 2, 2023
At Greenlight Guru, we pride ourselves on building products specifically for MedTech companies. With more than 1,100 customers worldwide, we take our mission to move MedTech... Read More
Establishing a QMS

Top 7 QMS Tools for MedTech (Plus 4 Bonus Resources)

Etienne Nichols
October 27, 2023
The FDA’s Quality System Regulation (QSR) and ISO 13485:2016 both lay out requirements for a medical device manufacturer’s QMS. (The two will soon be harmonized, but that’s... Read More
MedTech Lifecycle Excellence

What NOT to say to FDA

Etienne Nichols
October 26, 2023
In this comprehensive episode, Etienne Nichols and Mike Drues dive into the enlightening world of FDA inspections. Read More
Product Development

Ultimate Internal Audit Checklist: FDA QSR & ISO 13485 Audit Checklist

Etienne Nichols
October 25, 2023
It was nothing more than a checklist that saved $175 million and 1,500 lives. Read More
Establishing a QMS

QMSR Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

Etienne Nichols
October 20, 2023
On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulation (QMSR). Read More
Product Development

5 Foundational Steps of a CAPA Quality Process

Etienne Nichols
October 19, 2023
I have a bold opinion: The corrective and preventive action (CAPA) process is the 2nd-most important component of your quality management system (QMS). Read More
MedTech Lifecycle Excellence

Understanding LDTs & the FDA Proposed Ruling

Etienne Nichols
October 19, 2023
In this episode, host Etienne Nichols and Shannon Bennett, a regulatory affairs expert in the diagnostic testing space dive into the FDA's proposed rules for Laboratory... Read More

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