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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Private deployment · Sovereign infrastructure · Architecture session included

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 controlnon conformancecorrective action preventive actionaudit preparationtraining recordsequipment calibration

PRICING

Aligned to Operational Value, Not User Count

Pricing scales with deployment scope, not headcount. Your data. Your infrastructure. Your rules.

All plans include private deployment. Your data never leaves your infrastructure.

ISO 27001 Aligned
Private Deployment
Unlimited Users
Currency

Pilot

Validate before you commit

Custom

5 spots per quarter

  • Full platform deployment
  • Configuration support
  • Onboarding and training
  • Direct product team access
  • Feedback-driven iteration
  • 8-week evaluation period

Standard

Single-location operations

From $4,800 / month

per month, billed annually

  • All core platform capabilities
  • Standard template library
  • Private deployment included
  • Email support (24h response)
  • Quarterly platform updates
  • Unlimited users

Enterprise

Multi-location, high-compliance

Custom

Based on deployment scope

  • Everything in Standard
  • Custom template development
  • Dedicated support engineer
  • SLA guarantees
  • Advanced integrations
  • Air-gapped deployment option

Private Deployment Included in All Plans

Every plan includes full deployment on your infrastructure — Nextcloud, Linux servers, Docker, Kubernetes, or air-gapped environments. Your data never leaves your control.

Medical device quality evidence that regulatory bodies accept.

Private deployment on your infrastructure. Architecture session included.

Request Architecture Session