QMS for Life Sciences

Compliance made easy.

LinQMS streamlines the manual overhead of ISO 13485 and FDA requirements. Manage documents, traceability, and risk in one integrated platform.

LinQMS Interface

Standard-compliant software. Built simple.

Everything you need for ISO 13485 and 21 CFR Part 11. Without the corporate bloat.

Document Control

Structured workflows for creation, review, and e-signatures. Full audit trails included.

Risk Management

ISO 14971 compliant hazard analysis. Link risks directly to your design requirements.

Personnel Training

Integrated training matrix. Ensure every team member is qualified for their tasks.

Change Management

Engineering changes and deviations managed in one place. No more lost spreadsheets.

Audit Ledger

A permanent record of every action. Get ready for your next audit in minutes, not weeks.

Quality Events

CAPA and non-conformance tracking. Root-cause analysis that actually leads to fixes.

Traceability Visualized

LinQMS connects every record across your entire quality system. Documents, risks, parts, and trainings—all linked in a single, audit-ready tree.

Traceability Visualization Graph
Audit-ready in real-time

Simple pricing

Early Access

TBD/mo

LinQMS is currently in limited early access. Pricing will be finalized soon.

  • Full Document Control
  • Integrated Traceability
  • Personnel Training Matrix
  • Audit-Ready Infrastructure
  • Dedicated Onboarding Support

Regulatory Support

Our team of compliance experts is available 24/7 to help you configure your QMS for your specific regulatory needs.

Knowledge Base

Access templates, implementation guides, and best practices for ISO 13485 and FDA compliance.

Stop letting your QMS slow you down.

Built for ISO 13485 Compliance