Steps to Register a Medical Device in the USA
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...
