TGA Guidance for AI Screening Kiosk

Angebotsbeschreibung

I have developed an AI-driven, contact-less oral-health screening kiosk and now need to secure formal approval from the Therapeutic Goods Administration and obtain an ARTG listing. The device combines hardware, imaging sensors and embedded software (SaMD) to assess oral conditions without a clinician present, so the regulatory path is more complex than a standard medical device submission. My immediate goal is to move from a functioning prototype to full market release in Australia, which means: • mapping the correct TGA route for a Class I/IIa device with software, • closing any technical or clinical evidence gaps, • preparing the complete dossier and e-submission package, and • finalising the ARTG listing. I can supply all existing design files, risk-management docu...

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