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Quality
A medical device quality system, independently certified — and a surface that survives sterilization.
Certification
ISO 13485:2003 with CMDCAS
Restore has successfully completed the certification process for internationally recognized medical device specific quality management standards ISO 13485:2003 and the Canadian Medical Device Conformity Assessment System (CMDCAS).
Certification was conducted by BSI, one of the world’s leading certification bodies. Achieving these milestones demonstrates Restore’s commitment to providing the highest quality products to its customers, and brings the company a step closer to a global market presence.
The company also reports FDA clearance, patents filed for its products, technology and methodology, and product claims verified through independent laboratory testing.
- StandardISO 13485:2003
- CanadaCMDCAS
- CertifierBSI
- ClearanceFDA
- TestingIndependent laboratory validation
Material
MICRALOX® anodizing
Restore selected the highest quality anodizing in MICRALOX®: a patented aluminium oxide coating with a micro-crystalline barrier that revolutionises aluminium anodizing.
MICRALOX produces a long-lasting, virtually indestructible surface with dramatically superior chemical corrosion resistance, and eliminates colour fading due to super-heated steam. It is an excellent alternative to stainless steel, plastic and other materials.
In a process that runs through repeated wash cycles at high temperature, that is what keeps a colour-coded tray legible and a set identifiable.
Documentation on request
Certification details and validation reports were available from the company.