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.