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Sentium Bio stays in sync. Your product keeps its momentum.

AI regulatory coworkers that stay connected to your device and prepare your 510(k) in parallel, so your team can keep building.

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Your product keeps movingAgents work in parallelHuman review

Product development moves fast. Documentation falls behind.

Design changes, technical summaries, quality documents, and regulatory body guidance live in separate silos. The 510(k) draft cannot keep up with the product.

The source documents stay disconnected from the 510(k) draft, so teams work from different versions and the draft falls behind. Reconnecting the record takes time away from development.

The product moves forward.
The teams need a shared record.
Four isolated document silos for design changes, technical summaries, quality documents, and regulatory body guidance sit apart from a disconnected 510(k) draft that falls behind.
Design changes
Updates stay in an isolated design record.
Technical summaries
Key decisions live in a separate technical file.
Quality documents
Tests and quality evidence remain elsewhere.
Regulatory body
Guidance and requirements context sits outside the draft.
The document silos leave the 510(k) draft disconnected as it falls behind.

Sentium Bio agents maintain one connected workflow.

Your device documents and regulatory evidence give the agents context. That shared understanding supports the work your team needs throughout development.

The intelligence behind the work

Regulatory knowledge meets your device record.

FDA Knowledgebase

Agents draw on a connected corpus of FDA records, from product classifications and clearance summaries to postmarket safety data. That evidence puts your device in context before drafting begins.

  • 510(k) & predicates
  • Product codes
  • PMA & De Novo
  • MAUDE events
  • Recalls
  • Enforcement reports
  • UDI / GUDID
  • Registration & listing
  • FDA guidance
  • eCFR
  • FDA templates
  • Standards metadata

Product Understanding

Agents work with your ingested device documents to build a structured understanding of your product. Design details and intended use stay connected to the evidence, including hazard analyses and test reports.

Predicate Intelligence

Using that product understanding, agents identify candidate product codes and compare relevant predicates. A gap dashboard shows how your device compares and which evidence needs attention.

99.7% top-3 product-code accuracy

That context supports your daily work

The same device understanding carries through each answer, document, and review.

Chat

Ask questions in the platform or Slack. Find device information, summarize relevant research, and follow answers back to the source.

Draft

Create source-linked drafts using your templates and instructions. Agents use applicable FDA guidance and your SOPs to help your team spend less time on the first draft.

Review & Audit

Review documentation for traceability. Agents cross-check citations and references, flag inconsistencies, and surface missing evidence for your team to resolve.

Submission Readiness

See which 510(k) sections have supporting evidence and which still need work. Keep open gaps and review decisions visible as your team prepares the submission.

Follow a source into the record
Submission workspace/Device record
Human review
Source documents
Device recordSource linked

Intended use

The device is intended for use by trained healthcare professionals.

Device description.pdfSection 2.1

Bring one device.
Let’s talk.

We would love to hear what you're working on and show how we could help.

jae@sentium.bioFind us on LinkedIn (opens in a new tab)