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

Our Offer

    510(k) Document Preparation
    Acoustic Output Measurement
    Doppler Sensitivity Measurement
    Clinical Safety and Effectiveness
    Software Verification and Validation
    Engineering Compliance
    Electrical Test Coordination
    Users Manual Preparation and Labeling