Etienne Nichols

Engineer, consultant

 

 Etienne Nichols heads Industry Insights & Education at Greenlight Guru. As a mechanical engineer and medical device guru, he specializes in simplifying complex ideas, teaching system integration, and connecting industry leaders. While hosting the Global Medical Device Podcast, Nichols has led more than 200 interviews with professionals worldwide, moderated dozens of panels, and has continuously driven impactful conversations within medtech.

Wed, 01/19/2022 - 12:01
What Is a Class III Medical Device in the US?They are the only class subject to the premarket approval process
Thu, 04/25/2024 - 12:02
In the United States, the Food and Drug Administration (FDA) is the federal agency tasked with regulating the medical device market and ensuring the safety and effectiveness of all devices for patients. The FDA classifies medical devices by risk…
The Ugly Truth About Managing Design Controls on SpreadsheetsIt’s not the job that’s the problem. It’s the tools you have to do it with.
Wed, 12/06/2023 - 12:02
At one point in my career, after managing design controls and risk management documentation, I decided to move on. When the day came to put in my two-week notice, I walked over to another engineer’s cubicle with the news. “From now on,” I said, “…
Three Tips for Adding Flexibility to Your Medtech Manufacturing Supply ChainHow to give yourself a little more space when things happen
Thu, 09/21/2023 - 12:02
Supply chain management is crucial to any medtech company’s ability to deliver safe, effective, and high-quality devices to their customers. But as anyone in the industry can tell you, consistently getting the products and services you need to…
What FDA QSR and ISO 13485 Harmonization MeansQMSR for medical device companies
Wed, 08/09/2023 - 12:03
On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP)…
Making the Business Case for a New QMS SolutionAn eQMS buyer’s guide
Tue, 08/01/2023 - 12:03
Your company probably has an internal process for a large purchase like an eQMS. In midsize-to-large medtech companies, you’ll likely find this process in the finance department, or perhaps in a dedicated purchasing department operating under…
Fifteen Questions to Ask QMS Software Vendors in the Medical Device IndustryThe answers will reveal the truth about your product and get it to market faster
Wed, 07/26/2023 - 12:02
Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management…
How to Develop a Risk-Based Approach to Supplier ManagementDoing what’s best for your devices as well as your business
Wed, 07/05/2023 - 12:03
The goal of your MedTech company’s supplier management process should be to ensure a consistent supply of high-quality parts and components that conform to your specifications. But achieving that goal is easier said than done, and it depends…
Understanding ISO 14971 Medical Device Risk ManagementWith the right processes, you don’t have to reinvent the wheel
Tue, 06/13/2023 - 12:02
Medical device companies must have established risk management processes that comply with ISO 14971. It doesn’t matter whether you’re developing medical devices in the U.S., EU, Canada, or elsewhere. Every international regulatory agency you’ve ever…
Five Foundational Steps of a CAPA Quality ProcessA well-defined CAPA program is a framework for quality and effectiveness
Mon, 04/10/2023 - 00:02
I have a bold opinion: The corrective and preventive action (CAPA) process is the second-most important component of your quality management system (QMS). (If you want to know what I think is No. 1, shoot me an email.) As you build medical devices,…
Understanding the FDA’s Human Factors Guidance DraftWhat medical device manufacturers need to know
Mon, 03/06/2023 - 12:02
On Dec. 9, 2022, the U.S. Food and Drug Administration (FDA) issued a new draft guidance, “Content of Human Factors Information in Medical Device Marketing Submissions,” that provides recommendations for the inclusion of human-factors information in…