Integrated Assessment Services (IAS) assists firms in submitting a 510k premarket notice to the US Food and Drug Administration (US FDA). The 510k submission process provides a way for medical device manufacturers to easily sell their products in the USA. A medical device company’s 510k is a crucial document. It certifies to the agency that your product complies with public health and safety requirements, allowing you to list it as an FDA-approved device on your marketing labeling.