What I'm Building
Sentium Bio
An intelligence layer that works alongside builders — providing QMS-compliant documentation and a structured 510(k) submission pathway, so teams stay focused on making the product work while we handle the regulatory execution.
The problem
In regulated product companies, regulatory is treated as a last-mile documentation function. Teams wait to formalize strategy until after the product is working — by then, evidence is scattered, predicate logic is weak, technical decisions are embedded, and traceability has to be rebuilt after the fact.
Management is forced into bad options: slow product momentum to catch up on documentation, keep building while the regulatory gap widens, or bring in external consultants who are expensive, slow to ramp, and still dependent on scarce internal context.
What should be an execution plan becomes a reconstruction effort — costing months, six figures, and submission risk.
How we solve it
Sentium runs in parallel with product development. Specialized agents sit on top of your company documents and a structured FDA knowledge base to keep regulatory execution current as the product evolves.
- →Your docs + FDA sources — upload design files, test reports, and SOPs; the platform indexes them alongside real 510(k) records, CFR clauses, guidance docs, and MAUDE data
- →Agents that know your device — classification, predicate research, competitive intelligence, and regulatory strategy generated from your specific context, not generic templates
- →AI-assisted drafts — submission sections, QMS SOPs, risk assessments, and CAPA workflows drafted for you, traceable to governing clauses and ready to review, edit, and accept
- →Cross-section consistency — automated checks catch contradictions across your submission before you or FDA do
21 CFR Part 11 compliant audit trail. Human-in-the-loop on every output. Verified citations, not AI-generated regulatory text.
Built for
- •Seed to Series A medical device companies preparing for a first 510(k)
- •Founders and operators without deep in-house RA/QA support
- •Consultant-supported teams that want more structure and fewer surprises
- •Anyone tired of six-figure regulatory scrambles that still produce weak submissions
Looking for design partners, experts, and investors
I'm working closely with a small number of teams to shape the workflow around real submission pressure and real product momentum. If you're a founder navigating your first 510(k), an RA/QA leader who sees the gap, or an investor in regulated AI — let's talk.