Design Controls and Risk Controls

(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

If you’ve been watching the FDA lately, you might feel like you’re watching a daytime soap opera rather than a

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

This quick-read pulls from my “Medical Device 101” presentation, a session packed with field-tested guidance for

Think that the FDA won't notice your "therapeutic massager" device? Think they have much bigger fish to fry than your