The FDA has officially begun its shift from the decades-old Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR)
Prompting is a skill. Great prompts come from practice, experimentation, and learning from others.
In the medical device world, speed isn’t just a competitive edge — it can save lives. But time and again, we’ve seen promising technologies delayed or derailed not by safety issues, but by the slow, complex process of regulatory approval.
That’s why we built Agent Astro — to help regulatory professionals move faster, with more confidence and less friction.
Compliance isn’t enough anymore. The smartest MedTech companies are turning regulatory strategy into a competitive edge.
The right questions can save you weeks — or even months — in the approval process.
Predicate selection isn’t just a regulatory requirement — it’s a strategic lever that can reduce review time, prevent delays, and increase your chances of success.
The data is all there. The problem is finding it — fast enough to matter.
Innovation is accelerating — and regulatory strategy is finally catching up.
You’ve submitted before — so why does every new 510(k) feel like a fresh start?
Successful submissions aren’t guesswork — they’re grounded in precedent, precision, and strategy.
