Quality

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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 Group Quality Policy
ISO 13485:2016AuST Manufacturing
ISO 13485:2016CenterPoint Systems
MDSAPCenterPoint Systems
MDRCenterPoint Systems

Bring your auditors

We thought about writing pages on how rigorous our quality system is. Then we realized you should just come see for yourself.

We welcome your team scheduling an audit with us!

Documentation

ISO 13485:2016AuST Manufacturing — quality management systems for medical devices
Download PDF
ISO 13485:2016CenterPoint Systems — quality management systems for medical devices
Download PDF
MDSAPCenterPoint Systems — Medical Device Single Audit Program
Download PDF
MDR (Regulation 2017/745)CenterPoint Systems — Annex IX quality management system certificate
Download PDF
SSPC Delivery Catheter IFUCenterPoint Systems — instructions for use
View IFU
We can ramp.Not just a contract manufacturer.Regulatory expertise, in-house.Your idea is not just a print to us.R&D meets manufacturing.We de-risk your product launch.
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