Built for ISO 13485, EU MDR and 21 CFR Part 11
Six modules in one system. Changes, CAPAs and training records link to the documents and parts they concern.
Document Control
Documents move through a controlled workflow: draft, review, approval and release. Each approval is an electronic signature, and every revision is kept.
Risk Management
Supports ISO 14971 risk management. Hazards, risk controls and their verification link to the design records they concern.
Personnel Training
A training matrix shows who has completed training on which documents, and who is still due.
Change Management
Each change request holds its impact assessment and approvals, and links to the documents and parts it changes.
Audit Ledger
Every action is written to a hash-chained audit trail, so a changed or deleted entry can be detected.
Quality Events
Nonconformities and CAPA with root-cause analysis. A CAPA can't be closed until its effectiveness is verified, and editing it afterwards invalidates that verification.
Traceability between records
Documents, risks, parts, changes and training records are linked. From any record you can see what depends on it and what a change will affect.
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
LinQMS is in closed early access. We work closely with a small number of medical device teams while we develop the platform.
Request AccessQuestions before you apply?
Contact our team about the product, onboarding or how LinQMS fits your quality system.
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