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.
One Audit, Five Markets, Unlimited Potential for Medical Device Startups
Expanding a medical device startup globally is challenging, but regulatory harmonization offers a faster path to market. By leveraging the Medical Device Single Audit Program (MDSAP) and Mutual Recognition Agreements (MRAs), startups can streamline approvals, reduce compliance costs, and enter multiple markets efficiently. Learn how leading medical device companies are using these strategies to scale faster.