How to Market a Medical Device in the U.S. and What You Need to Know

2026.10.23

The U.S. remains one of the most competitive and tightly regulated markets for medical devices. But even with a high-quality product, many companies face costly delays—not because of flaws in technology, but due to gaps in documentation or misunderstanding of regulatory requirements.

FDA Medical Device Webinar: IFU and Labeling

2026.10.23

Hansem Global is co-hosting a webinar with Amin Wasserman Gurnani (AWG), a U.S.-based FDA regulatory law firm, on what it takes to bring a medical device to the U.S. market. “How to Get It Right: Legally Launching a Medical Device in the U.S.” brings legal…