Of course, Inomed Technology is ISO-13485 certified through the BSI. We are equally licensed as a cases manufacturer by the FDA.
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,
- PPSU brackets resistance test through multiple autoclaving,
- Inovis M5x8 resistance test to oxidation in autoclave,
- Influence of pin-etched brackets in autoclave,
- 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.
The following documents are also available :
- Inomed quality manual,
- Instructions for use.
A copy of these reports can be sent upon request.