510(k) Submission

You can’t afford for FDA compliance to be an afterthought.

The United States is one of the world’s largest markets for the healthcare industry due to its unique combination of population, capital, and overarching regulations. For medical device and software companies, adhering to FDA standards and regulations  is both complicated and absolutely necessary.  We have assisted multiple healthcare clients in the development and documentation of their solutions and have secured 510(k) clearance (previously known as premarket notification) for over a dozen solutions.