Built for Medical Device Teams that Need Their
Quality Management System to be Faster, Simpler, and Affordable
Designed for Medical Device Teams Working Under:
FDA QMSR / 21 CFR Part 820 · ISO 13485 · ISO 14971 · 21 CFR Part 11 · EU MDR · Related Quality Requirements
Medical device teams need strong quality processes, but most teams are forced to choose between messy shared drives and expensive legacy eQMS platforms.
Files get duplicated, approvals get missed, and teams waste time tracking quality work manually.
Clunky workflows, outdated software, and expensive services make quality management harder than it needs to be.
Teams spend hours chasing signatures, updating trackers, linking records, and repeating work across disconnected systems.
Helian helps medical device teams manage quality work in one simple, intuitive, and affordable system, with AI to help draft content, review records, spot gaps, and reduce repetitive work.
Haley AI helps your team draft, improve, review, summarize, and complete quality work faster, while keeping your team in control of every QMS decision.