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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

Nonconformance (NC) and CAPA: When Should You Use Each Process?

December 2, 2022
Your nonconformance (NC) and Corrective Action and Preventive Action (CAPA) processes are two critical elements within your quality management system. Read More
Product Development

What "Exempt" Means with Respect to Medical Devices & Regulatory

November 30, 2022
How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a... Read More
Product Development

Developing a Regulatory Strategy

November 23, 2022
What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn’t? Those are the questions that today’s guest, Mike... Read More
Product Development

What Device Makers Need To Know About Design Verification and Validation

November 21, 2022
Design verification and validation are two essential steps in medical device product development. It’s easy to confuse the two, but there’s a simple way to remember them: Read More
Product Development

Understanding Root Cause Analysis in the CAPA Process

November 20, 2022
Corrective and preventive actions (CAPA) is a cornerstone to ensuring the quality of medical device manufacturing. Perhaps that’s the reason why improper CAPA procedures are... Read More
Product Development

We Achieved ISO Certification! Now what?

November 16, 2022
What are ISO 9001 and ISO 27001? Once you have them, what can you do with them? These are the questions you’ll hear Mark Alpert answer in today’s episode. Read More
Product Development

The Future of Reprocessed Used Medical Equipment

November 10, 2022
What’s accelerated the growth of online healthcare device sales, and what’s the future of regulation regarding selling used medical devices? In today’s episode, we... Read More
Product Development

The Importance of Cervical Cancer Screening in the U.S.

November 4, 2022
The importance of cervical cancer screening in the U.S. Why is cervical screening so important in the U.S. and globally? And how has the pandemic affected that... Read More
Product Development

Customer Discovery for Medical Device Companies

November 2, 2022
What is the customer’s ecosystem, and why do you need to know about it? In today’s episode, we spoke with Kari Haab about Customer Discovery for Medical Device... Read More

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