Upgrade from chaos to compliance — without the corporate bloat
Leima QMS is the fastest way to move from Google Docs, PDFs, and shared folders to a real, auditable QMS.
Built for early-stage medtechs that want to grow — not drown in paperwork.
Most quality systems fall into two camps: chaos or complexity.
Some teams build their QMS from scratch — scattered documents, unclear approvals, no audit trail.
Others get locked into bloated systems that require consultants just to operate.
Both are painful.
Neither fits a fast-moving medtech company.
You need something purpose-built: simple enough for founders, solid enough for ISO 13485.
Built for lean teams.
Instead of wrestling with enterprise software or duct-taping tools together, Leima QMS gives you:
- A single place to manage all your controlled documents
- Built-in templates to get compliant fast
- Customization where you need it
- Multi-stage approval workflows
- Full versioning, approvals, and audit logs — no extra setup
- And AI agents that help write, check, audit and improve your quality system as you go
Whether you're starting from scratch or replacing a system that’s holding you back, Leima QMS gives you the confidence to scale quality without the overhead.
Don't wait until the audit to get serious
Your quality system doesn’t need to be complex — it needs to be clear.
Leima QMS gives you the right amount of structure to grow with confidence.