Compliance
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ISO 9001 & ISO 13485 certified. Full documentation available for regulatory submissions.
Market compliance
| Market | Framework | Status |
|---|---|---|
| European Union | EU MDR 2017/745 | ISO 13485 aligned |
| United Kingdom | UK MDR 2002 | UKCA pathway supported |
| United States | FDA 21 CFR Part 820 | 510(k) support available |
| GCC / Middle East | SFDA / MOHAP | Active exports |
| Australia | TGA (ARTG) | Active exports via sponsors |