Content by Etienne Nichols
CAPA for PremarketYou need less than you think
Wed, 09/02/2026 - 12:02
Ask a premarket team where corrective and preventive action (CAPA) sits on the priority list, and it usually lands below design controls, risk management, and the submission itself. The reasoning is easy to follow. Nothing has shipped, so there are…
What the Purolea Warning Letter Really Means for AI in MedtechIf you think it’s an AI story, you’re missing the point
Tue, 06/16/2026 - 12:02
The U.S. Food and Drug Administration’s April 2, 2026, warning letter to Purolea Cosmetics Lab is making the rounds, mostly under some version of “FDA cracks down on AI in manufacturing.” That’s the wrong way to read this. If you build medical…
Understanding 21 CFR Part 820The ultimate guide to the FDA’s quality management system regulation
Tue, 03/17/2026 - 12:02
In the medical device industry, compliance isn’t a pop quiz. The U.S. Food and Drug Administration (FDA) has given you all the answers to the test in the form of a regulation: 21 CFR Part 820. That doesn’t mean it’s easy to ace the test. But you now…
Carrying Out a Supplier AuditWhen and how to audit your suppliers
Tue, 08/12/2025 - 12:03
Good supplier management is one of the most important methods of building a safe and effective medical device. A single device may be made up of dozens of parts and components coming from several different suppliers, and many medical device…
5 Key Elements of an Effective CAPA SystemCommon challenges medtech companies face, and how to overcome them
Tue, 07/15/2025 - 12:02
The corrective and preventive action (CAPA) process is one of the most important elements within a medtech company’s quality management system (QMS). The goal of the CAPA system is to identify, address, and prevent systemic issues that could…
FDA Guidances on AI-Enabled DevicesWhere AI stands in 2025
Tue, 07/01/2025 - 12:02
As part of its effort to address the changing landscape around artificial intelligence (AI) in medical devices, the U.S. Food and Drug Administration (FDA) has recently released two new guidance documents on artificial intelligence-enabled device…
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…