Our Quality and Safety Guarantee

  • At AuST, quality assurance is paramount. Our manufacturing facilities and processes are fully compliant with industry and International standards for medical device design and manufacturing.
  • AuST Quality Policy: AuST is built and maintained to design and manufacture high quality, innovative products that meet the requirements of its customers, regulators, and ultimately those of product end users.
  • AuST Manufacturing is certified to ISO 13485:2003 with the following Scope: Design, Development, and Manufacture of Catheters, Sheaths, and Minimally Invasive Tools and Related Sub-Assemblies, Components, and Accessories.

Click here to review our ISO 13485 Certificate

Click here to learn more about our Regulatory and Clinical Support on our Development website.