USA

For medical device manufacturers seeking market access or maintaining compliance in the United States, understanding US FDA inspections is critical. These inspections play a major role in determining whether a product remains on the market, receives premarket approval, or becomes the subject of regulatory action. In 2025, the USFDA inspection process continues to evolve, with more focus on risk-based inspections, post-market surveillance, and digital documentation. This guide explains what to ex...

Bringing a medical device to market in the United States is a major milestone but it’s also a highly regulated process. The U.S. Food and Drug Administration (FDA) oversees medical device regulation to ensure the safety, effectiveness, and performance of devices used by healthcare professionals and patients At OMC Medical, we specialize in guiding manufacturers through this intricate pathway. Whether you are a first-time entrant to the U.S. market or expanding your global footprint, understand...