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 that updates dynamically as your team works.
Simple pricing
Early Access
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
Early Access Program
We are currently in closed early access, partnering closely with design-focused life science teams to refine the platform. Apply today to secure your spot.
Request AccessKnowledge Base
Access templates, implementation guides, and best practices for ISO 13485 and FDA compliance in modern development environments.