How does the 30-day free trial work?

Register your credit card to access all features for 30 days. No charge until the trial ends. Cancel anytime with no commitment.

Your data stays on your own infrastructure (on-premise or private cloud). We use SSL/TLS 256-bit encryption, comply with GDPR, and align with ISO 27001. We never access your operational data.

How long does implementation take?

Basic implementation takes 1-2 days. For enterprise deployments with custom integrations, typically 1-2 weeks. Configuration support is included in all plans.

Does it work without internet?

Yes. Certexi operates locally on your network. Offline mode allows full operation for up to 60 days without connectivity. Data syncs automatically when connection is restored.

Global (EU, US, Canada, Australia)

ISO 13485 compliance with evidence that FDA and notified bodies accept

ISO 13485:2016 — Medical Devices Quality Management Systems

Design controls, process validation evidence, traceability records, and CAPA management — built into medical device operations with the rigor ISO 13485 demands.

Notified Bodies (EU MDR), FDA (as part of QSR), Health Canada, TGAGlobal (EU, US, Canada, Australia)

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About ISO 13485

ISO 13485:2016 is the quality management system standard for medical device manufacturers. It emphasizes documentation, traceability, and risk management throughout the device lifecycle.

Top audit finding

"Incomplete device history records with gaps in traceability chain"

Most common ISO 13485 non-conformance finding

Requirement mapping

ISO 13485 requirements — and how Certexi addresses them

Framework requirements

1Device design and development controls with documented evidence
2Production and process controls with in-process inspection records
3Full device traceability: components to finished device to distribution
4Equipment calibration and validation records
5CAPA system with root cause analysis and effectiveness verification
6Post-market surveillance and complaint handling records

Certexi approach

Device history records: complete lifecycle from materials to distribution, immutably sealed
Calibration management: schedules, certificates, out-of-tolerance workflows with product impact
CAPA workflow: source-to-closure with mandatory RCA and effectiveness verification
Complaint handling: receipt, investigation, regulatory reportability decision, all documented
Audit bundle: organized by ISO 13485 section with evidence for any audit period

Industry relevance

Sectors where ISO 13485 compliance applies

Manufacturing & Operations

Healthcare & Pharma

Core capabilities

Use cases central to ISO 13485 compliance

document control non conformance corrective action preventive action audit preparation training records equipment calibration

PRECIOS

Alineado al Valor Operativo, No al Número de Usuarios

El precio depende del alcance del despliegue, no del número de usuarios. Tus datos. Tu infraestructura. Tus reglas.

Todos los planes incluyen despliegue privado. Tu información permanece en tu infraestructura.

ISO 27001 Aligned

Private Deployment

Unlimited Users

Piloto

Valida antes de comprometerte

Personalizado

5 lugares por trimestre

Despliegue completo de plataforma
Soporte de configuración
Capacitación e incorporación
Acceso directo al equipo de producto
Iteración basada en retroalimentación
Período de evaluación de 8 semanas

Estándar

Operaciones de una ubicación

Desde $2,500

por mes, facturado anualmente

Todas las capacidades centrales
Biblioteca de plantillas estándar
Despliegue privado incluido
Soporte por email (respuesta 24h)
Actualizaciones trimestrales
Usuarios ilimitados

Enterprise

Multi-ubicación, alto cumplimiento

Personalizado

Basado en alcance del despliegue

Todo lo de Estándar
Desarrollo de plantillas personalizadas
Ingeniero de soporte dedicado
Garantías SLA
Integraciones avanzadas
Opción de despliegue air-gapped

Despliegue Privado Incluido en Todos los Planes

Cada plan incluye despliegue completo en tu infraestructura — Nextcloud, servidores Linux, Docker, Kubernetes o entornos air-gapped. Tu información nunca sale de tu control.

Medical device quality evidence that regulatory bodies accept.

30-day free trial. Private deployment on your infrastructure.

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