Inomed Technology SA and NTOC Medische Techniek are both certified ISO 13485 by BSI and DEKKRA, respectively. Regarding risk management for medical devices, we work according to the latest ISO 14971 standard.
Inomed Technology SA is licensed as a contract manufacturer of baskets with the FDA.
The baskets manufactured by NTOC Medische Techniek are classified as Class I medical devices in accordance with REGULATION (EU) 2017/745 (MDR) and also bear the CE quality marking.
Testing and Validation of Our Components
We have conducted a series of tests and validations on our components, including the following analyses (a copy of the reports will be sent upon request):
- Bio-burden test
- Sterilization test
- Drop test
- Stress test (behavior of the silk-screen printing during multiple autoclave cycles)
- Cytotoxicity test
- Sterilization resistance test for PPSU supports
- Oxidation resistance test in the autoclave for Inovis M5x8
- Influence of bracket engraving on sterilization
We have also conducted the following studies
- Risk analysis
- Essential requirements checklist
- Medical device characteristics
The following documents are available to you
- Quality manual
- Instructions for use
