Quality Regulatory

    Hantel maintains a comprehensive quality system which encompasses design, manufacturing, and service activities. We are licensed by the State of California and registered with the FDA as a manufacturer of Class I, II, and III medical devices. We are also ISO-13485 registered. For products that require FDA clearance prior to entering the market, we can actively manage IDE applications, IRB approvals and 510(k) applications. In addition, Hantel can assist our clients in obtaining their CE mark, helping to expedite entry into the European market. As your company matures, we can also facilitate the development of your own quality system.