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FAQ
No. GORA AI provides informational guidance for planning and product development. Real submissions require qualified regulatory review and company-specific evidence.
EU MDR, FDA/CDRH, Swissmedic, China NMPA, Japan PMDA/MHLW, Brazil ANVISA, and Australia TGA — with more on the roadmap.
Yes. Create a workspace and run a device through the full classification and dossier workflow right away.
The assistant answers only from curated source records and cites them. When source coverage is insufficient, it tells you instead of guessing.