Quality Policy

We strive to provide products and services with the aim of exceeding customers' expectations. Strongly focused on continuous improvement, we monitor and respond to needs, complying with all regulatory requirements.

Össur operates a strict and effective quality control system, meeting all ISO 9001 and ISO 13485 requirements. All of Össur's products are designed to provide comfort and high-level performance. Products are CE-marked and conform to standards and other normative documents outlined in each separate EC (CE) Declaration of Conformity.

Össur EC Declaration of Conformity

Össur EC Declaration of Conformity Bracing & Supports

Össur Quality Certificate ISO 9001:2008

ISO Certificate 9001 Gibaud

ISO Certificate 9001 Euromedical 

ISO 13485:2003 Certificate CMDCAS

ISO 13485:2003 Certificate UKAS

ISO 14001:2004 Certificate

CE Certificate

Certificate of Registration 

Health Canada License

Health Canada Cold Rush License

PROPRIO FOOT EMC pass Certificate

OEKO-TEX® Certificate

POWER KNEE CB Certificate

Reference

FDA device listing

International Organization for Standardization

Information on CE markings

European Union information on CE markings