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.

The Work
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

Hantel Technologies

"Nice work on seeing...

this through to a successful approval.”

"The CAPA is very...

thorough and well written.”

Looking for a flexible medical device partner? Contact us today.