Before marketing a medical device in the US, or reintroducing a device that has been modified affecting safety or effectiveness, medical device manufacturers need to submit to the Federal Drug Administration FDA a pre market notification or 510(k) and demonstrate by testing and documentation that it is substantially equivalent to an already marketed device and that no new safety or effectiveness concerns are introduced.

Sigma Biomedical provides complete regulatory consulting services for Federal Drug Administration (FDA) 510(k) submissions, as well as for other medical regulatory affairs needs, such as the Medical Device Directive MDD CE mark or FDA Quality Systems Regulation QSR compliance. Sigma's regulatory, engineering and scientific team can efficiently help you achieve FDA SE notices.

Sigma Biomedical goes beyond traditional regulatory consulting giving you the advantage of an engineering team that also assists in medical product development and testing. Experienced engineers who understand the product development process will work with your team so the device gets ready for submission efficiently meeting FDA regulations, saving your company precious testing time and money