Helian is the electronic QMS for medtech startups — document control, design & risk, CAPA, training, and audit-ready records in one connected system, without the enterprise bloat.
Building a medical device requires rigorous documentation — but the tools used to manage quality often create more work than they solve.
Documents get duplicated, changes become difficult to track, and proving compliance becomes a manual process.
Long implementations, complex workflows, and expensive consulting requirements slow down small teams.
When records live across multiple systems, every audit becomes a hunt for documents and evidence.
Helian brings document control, change management, design & risk, training, suppliers, and post-market compliance into a single platform — so every record links to the next and nothing lives in a silo.
Haley handles the writing-heavy parts of quality work — so your team spends time on the device, not the documentation.
No consultants. No six-month rollout. Bring what you have and start working.
Start from pre-built templates or bring your existing SOPs and records. Your quality system, structured the way you work.
Create, review, approve, and electronically sign — all in one place, with linking and traceability handled for you.
Every action is time-stamped, traceable, and audit-ready — so a records request is a search, not a scramble.
Start with what you need today. Helian is designed to grow with you — add modules as you scale, without ever re-implementing the system underneath.
Bring your existing SOPs and records, or start from templates. Helian is designed so a small team can be working in the system in weeks, not the months a legacy rollout takes.
Helian is built around ISO 13485 and FDA 21 CFR Part 820, with 21 CFR Part 11 electronic signatures and a complete audit trail on every record.
No six-figure implementation and no enterprise bloat. Helian is priced for startups and built for the way a small team actually operates.
See how Helian keeps your quality system audit-ready without slowing your team down.
See the platform