Compliance.
Simplified.
A central platform for continuous traceability of medical software — from commit to audit package.
Built for manufacturers of medical software in Norway and the EU/EEA.
Traceability, monitoring, documentation.
Three core capabilities covering the entire software life cycle per IEC 62304.
Server heartbeat
Live monitoring of kernel versions, backup status, security updates and service status every 10 minutes. Documents IT security per MDR Annex I §17.2.
Risk and requirements
Risk analysis per ISO 14971, software requirements per IEC 62304, and a traceability matrix that binds commits, PRs and verifications to the requirements.
Audit package
One click generates a complete PDF for the regulatory authority — with configuration management, risk register, change log and SOUP overview ready for inspection.
Built around the framework.
Medivox Compliance Portal — Class I medical software under MDR (EU) 2017/745. 23 policy documents cover MDR, IEC 62304, IEC 81001-5-1, ISO 14971, ISO 13485, ISO/IEC 27001:2022, GDPR, NIS2 and CRA.
Built for sensitive data.
All traffic over TLS. API tokens are stored as a SHA-256 hash — plaintext is never stored. A complete audit log of who registered and changed what. Data classification per server documenting GDPR transfers.