Latest Updates & Insights
Stay informed with the latest developments in medical device regulations, technology trends, and industry best practices.
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, grab a stuffie, and learn how we’re transforming FDA submissions with AI.
Recent Articles
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.
Biocompatibility: Why ISO 10993 Isn’t Just a Box-Check ?
Biocompatibility is a critical component of medical device safety and effectiveness. But it’s also an area where many submissions fall short—not because the science is lacking, but because the documentation and rationale don’t meet FDA expectations.