Updates & Insights
Stay informed with the latest developments in medical device regulations, technology trends, and industry best practices.
The ROI of Regulatory Intelligence: Why Agent Astro Pays for Itself
Agent Astro was built to solve this problem by reducing the hours lost to manual research and verification and by helping teams produce higher-quality regulatory work with greater confidence.
Recent Articles
Meet Agent Astro at the MedTech Conference — Booth 728
Join thousands of industry leaders October 5–8, 2025, in San Diego. And make sure to stop by Booth 728 to see Agent Astro in action, pick up a conference giveaway, and learn how we’re transforming FDA submissions with AI.
QSR is out. QMSR is in. Here’s what that means for your FDA strategy.
The FDA has officially begun its shift from the decades-old Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR)
Cybersecurity in Medical Devices: From IT Risk to Patient Safety
Cybersecurity as a core safety concern, the FDA is reshaping how manufacturers design, test, and defend their devices. With the right tools, companies can not only meet these expectations but also gain a competitive advantage by delivering devices that are safe, trusted, and market-ready.