Quality & Regulatory
Quality & Regulatory Process
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 contract manufacturer. 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 OUS regulatory approval, helping to expedite entry into the global market. As your company matures, we can also facilitate the development of your own quality system.
We Do Serves
a Higher Purpose.
Independent Testing Capabilities
Our in-house laboratory performs independent mechanical, functional and device performance testing services that comply with ISO/IEC and other relevant recognized industry standards. Hantel is also audited on an annual basis by a Notified Body to make sure we maintain a high standard of compliance. For example, product compliance testing to the following standards:
- View/Download our ISO 13485:2016 Certificate
- ISO 10555 Intravascular catheters – Sterile and single-use catheters – Part 1: General requirements
- ISO 80369 – Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements
What people are saying about
"Nice work on seeing...
this through to a successful approval.”
"The CAPA is very...
thorough and well written.”