Content by Etienne Nichols
Five Common Regulatory Pitfalls in the Medical Device IndustryAnd how to avoid them
Thu, 04/17/2025 - 00:02
What’s your favorite regulatory pitfall? I know that’s a strange question, but if you’ve spent much time in the medical device industry, there are likely a few that come to mind. People reach out to me all the time asking how to break into the…
Three Insights on Medtech Product DevelopmentTake it from an ex-FDA investigator
Wed, 03/19/2025 - 12:02
Have you ever wondered what your medtech company looks like from the point of view of a U.S. Food and Drug Administration investigator? Well, this is your chance to find out. Greenlight Guru invited Vincent Cafiso, a former FDA investigator, to the…
Medical Device ComplianceRegulations, standards, and solutions
Wed, 12/18/2024 - 12:02
Compliance with industry regulations and standards is a fundamental part of medtech. Without proper medical device compliance, companies risk patient harm, litigation, and reputational damage. Fortunately, compliance with medical device regulations…
Should You Invest in Quality Management Consulting?How and when to seek help
Thu, 12/12/2024 - 12:02
A quality management system (QMS) is at the heart of every successful medtech company. A QMS comprises all the policies, processes, and procedures that ensure the production of safe and effective medical devices—which means that problems with your…
The Five Elements to Connect to Design Controls for an Audit-Proof QMSFrom risk analysis to CAPA
Wed, 08/28/2024 - 12:01
Design controls are a set of quality practices and procedures used to ensure that a finished device meets its user needs, intended use, and specified requirements. The requirement for medical device companies to use design controls is established…
What FDA QSR and ISO 13485 Harmonization Means for Medical Device CompaniesThe new QMSR explained
Tue, 08/06/2024 - 12:02
On Jan. 31, 2024, the U.S. Food and Drug Administration (FDA) released its final rule for the new Quality Management System Regulation (QMSR). The new QMSR is the result of aligning the current good manufacturing practice (cGMP) requirements of the…
QMSR and the End of DMR, DHR, and DHFHow the FDA’s new rule affects record-keeping
Wed, 06/26/2024 - 12:02
If you’re a medtech professional who’s been working with the quality system regulation (QSR) in the United States, then you’re probably familiar with the three terms the U.S. Food and Drug Administration uses for record-keeping requirements: 1)…
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…