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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.

Establishing a QMS

Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions

March 17, 2023
One of the most critical decisions a MedTech company will make is choosing the right quality management system (QMS) solution. The QMS solution you choose will have a... Read More
Product Development

V&V Activities from a Verification Engineer POV - How Hard Could It Be?

March 15, 2023
What’s the difference between design verification and validation, and why is it so important? Read More
Product Development

Top 30 MDCG Guidance Documents for Medical Device Companies

March 13, 2023
The Medical Device Coordination Group (MDCG) is a regulatory body made up of industry experts appointed by each of the member states of the European Union. Read More
Product Development

Top 40 IMDRF Technical Documents for Medical Devices

March 10, 2023
The International Medical Device Regulators Forum (IMDRF) is a global organization on a mission—a mission to enhance the safety and quality of medical devices and promote... Read More
MedTech Lifecycle Excellence

Understanding the 'Compliance Manager' Role

March 8, 2023
What are the challenges in managing compliance and the difference between compliance and quality management positions? You’ll learn more by listening to today’s guest. Read More
Product Development

How to Define User Needs During Design Controls

March 3, 2023
Every medical device begins with the same purpose—to improve the quality of life by meeting the needs of its users. Read More
Establishing a QMS

21 CFR Part 11: A Complete Guide

March 3, 2023
Medical device companies that wish to sell their devices in the US and EU must implement a quality management system that meets the requirements of 21 CFR Part 820 and ISO... Read More
MedTech Lifecycle Excellence

DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact

March 1, 2023
DHF, DMR, and DHR are easy to mix up when you’re just using the abbreviations – they sound a lot alike! And they are connected. But it’s important to understand the... Read More
Product Development

Does My Device Labeling Comply with 21 CFR 801?

February 28, 2023
Medical device labeling is a core requirement for getting your device onto the market. 21 CFR 801 covers general device labeling and the use of symbols. One thing the... Read More

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