ISO 13485 certification

Of course, Inomed Technology is CE-13485 certified through the BSI. We are equally licensed as a cases manufacturer by the FDA.

Certificat bsi Inomed

Tests and validation of our components

We have conducted a number of quality tests in order to validate our case components, for instance:

  • Bio-burden test,
  • Sterilisation test,
  • Drop test,
  • Stress-test (check the capacity of silk-screening to resist to multiple autoclaving),
  • Cytotoxicity test,
  • Sterilisation test of our PPSU corner protection skis,
  • Resistance test to oxidation in an autoclave (304 steel MCH / MDC 304),
  • PPSU brackets resistance test through multiple autoclaving,
  • Inovis M5x8 resistance test to oxidation in autoclave,
  • Bioburden and sterilisation test of our INOdiamond silicone mat,
  • Influence of pin-etched brackets in autoclave,
  • Phoenix corners sterilisation test,
  • Silk-screening resistance test through washing and sterilising with cleaning agents between pH 4 and pH 12.

We have established the following studies :

  • Risk analysis,
  • Essential requirements checklist,
  • Medical devices characteristics "Inotray sterilisation trays and accessories".

The following documents are also available :

  • Inomed quality manual,
  • InoTray general Instructions for sterilisation,
  • InoTray declaration of conformity.

A copy of these reports can be sent upon request.