Regulatory Borders Are Blurring, But Your Compliance Strategy Still Needs Sharp Lines
The billion-dollar question haunting every medical device startup: Can we finally build one quality system for both sides of the Atlantic? The FDA's new QMSR and the EU MDR both reference ISO 13485, creating a misleading impression of regulatory harmony. Startups treating these systems as interchangeable often face compliance catastrophes, inspection delays, and documentation disasters that can torpedo market launches before they even begin.
How Global Regulatory Trends Are Quietly Shaping FDA Reviews
Global regulators are converging on how they evaluate AI and software in medical devices. The IMDRF’s 2025 guidance, FDA-EMA alignment, and new international standards are redefining what compliance means—shaping U.S. submissions and timelines for global startups entering the MedTech market.