Regulatory File Submission Support
Medical device submissions are formal documents and data packages provided by an OEM to regulatory authorities for approval to legally market a medical device in a country or region. These submissions demonstrate that a device is safe, effective, and compliant with applicable laws and standards.
Schivo fully supports the medical device OEM’s requirements for regulatory file submissions. In addition, our company is registered with the U.S Food and Drug Administration (FDA) and complies with or exceeds their quality system requirements. Schivo is among the few contract manufacturers with a production management platform that records, tracks, and stores each part’s data for future reference. This rigorous quality assurance process ensures the component meets or exceeds OEM specifications, plus provides the part’s production history for regulatory submission purposes.
Schivo’s robust quality system mirrors those of the medical device OEMs and fully supports the regulatory bodies’ file submission requirements.
