What FDA’s Purolea Case Teaches About AI, Quality Systems, and Compliance Risk

The warning letter to Purolea Cosmetics reads, at first glance, like a cautionary tale about artificial intelligence in

Most medtech founders don’t run out of vision. They run out of time, money, or credibility—usually in that order. After

Every year, people ask whether FDA enforcement is “getting tougher.” There’s no denying that things are changing at the

(This blog was derived from a presentation featuring Michelle Lott and Renae Franz from leanRAQA and Fernada Nusbaum

If you’ve worked in medical device regulatory or quality for longer than five minutes, you already know the

Nothing inspires dread quite like the phrase quality management system. For many, the term “QMS” conjures images of

If you’ve dipped even a toe into the muddy waters of 510(k) submissions, you already know one big truth: pick a

Investing in medtech starts with one very important truth: it’s all about time and money. While founders talk

If you’ve ever thought, “We’ll figure it out when we file” (admit it - you've at least thought it) then you know what

The FDA isn’t a monolith. Well, it IS, but it’s also fallible, inconsistent, fluid and sometimes surprising - which is