The workspace for FDA 510(k) submissions.

Sentium Bio agents read your device sources, organize the evidence, and keep every claim traceable to where it came from.

Data starts scattering into different silos.

Device history, test reports, predicate notes, and drafts live in separate files and inboxes, disconnected from each other.

Then work alongside to map the regulatory strategy.

As the device evolves, agents keep the regulatory picture current, so the record and the product stay in sync.

Each agent reads your sources, holds the regulatory context, and keeps every output backed by source documents.

Search and link FDA records: product codes, classifications, guidance, and cleared devices, connected into one navigable map.

Agents ingest your device documents and build a structured picture of intended use, design, and current state from the start.

Agents research the relevant product codes and predicate candidates, with the cleared-device evidence behind each one.

Agents draft and audit documents, match the IFU, and assemble source-linked 510(k) sections for human review.

Every output is grounded in your sources and FDA records, with the citation visible. People review and decide.

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