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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.

Product Development

Understanding The Relationship Between Usability and Labeling of Your Medical Device

July 3, 2022
Though they span a huge spectrum of applications, all medical devices are created for the same purpose: to improve the quality of life for their users. Read More
Product Development

4 Letter to File Mistakes That Could Cost You

June 24, 2022
Innovation in medical device technology happens quickly - not only with new product designs, but also with improvements made to existing devices. Read More
Product Development

3 Stages of Project Management in the Medical Device Industry & How to Navigate Each

June 17, 2022
Stepping into the role of project manager at a medical device company is a unique and exciting experience. It’s also a challenge, but if you’ve decided to take on this role,... Read More
Product Development

5 Strategies to Limit Project Timeline and Cost for your Medical Device

May 30, 2022
Creating success in the medical device industry is about sustainable growth and repeatable processes. But all of that is really a longer way of saying “change management.” Read More
Product Development

How to Build a Medical Device Business Case in 5 Easy Steps

May 16, 2022
In business, so much of success depends on timing. A product launches too early and is misunderstood by the market; a product launches too late and becomes another face in... Read More
Product Development

Performance Evaluation Under EU IVDR: Proving Your IVD’s Performance

May 5, 2022
A Performance Evaluation (PE) is required for any in vitro diagnostic device (IVD) that a manufacturer wants to place on the EU market. Read More
Product Development

30/60/90 Day Plan to Making an Impact as a New QA/RA Manager

May 1, 2022
Starting a new job is always a little stressful. But when you’re a new QA/RA Manager, there’s even more pressure than usual. It’s not a stretch to say that the fate of this... Read More
Product Development

Post-Market Clinical Follow-up Under EU MDR: Your Guide to PMCF Activities

April 28, 2022
The post-market clinical follow-up (PMCF) is one of several forms of post-market surveillance stipulated by the European Union Medical Device Regulation (EU MDR). Read More
Product Development

3 Tips for Planning a Successful Product Development Project for Your Medical Device

April 24, 2022
If you’ve ever been involved in the design and development of a medical device, you know just how complex the process really is. Not only are you attempting to create the... Read More

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