Healthcare & Pharma

Medical device maintenance records that satisfy Joint Commission auditors

Equipment lifecycle, preventive maintenance schedules, calibration records, and incident documentation — all maintained on your infrastructure with complete audit trails.

joint commissionfda 21 cfr part 820iso 13485dnv gl
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Private deployment · Sovereign infrastructure · Architecture session included

The problem

Why existing approaches fail

  • ×Medical device maintenance records scattered across biomed department systems and paper files
  • ×PM completion rates tracked in spreadsheets that do not link to the actual maintenance evidence
  • ×Joint Commission auditors request records for specific devices that require locating across multiple sources

The Certexi approach

Evidence generated at the point of work

  • Device registry with complete lifecycle: acquisition, maintenance history, calibration, and disposition
  • PM workflow: schedule → perform → document with photo evidence → sign off → seal
  • Joint Commission audit bundle: any device, any period, with all maintenance events and certificates

Compliance coverage

Regulatory frameworks supported

Evidence generated by Certexi is designed to satisfy the requirements of these frameworks.

JOINT COMMISSIONFDA 21 CFR PART 820ISO 13485DNV GL

Related capabilities

Use cases that power this solution

equipment calibrationaudit preparationincident reporting

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.

On-Premise Deployment
Offline-First
ISO 27001 Ready
Sovereign Deployment

Ready to generate medical device maintenance & compliance evidence automatically?

Medical equipment compliance built into every maintenance event.

Request Architecture Session