IEC 62304

Requirements Software for support of IEC 62304

What is IEC 62304 with Visure Requirements

Visure Requirements offers complete and agile artifact management for the development and verification of medical device software.

It provides end-to-end traceability between risks, requirements, verification items, problem reports and project artifacts in one single environment and through the integration with other tools of the lifecycle. This helps organizations in enforcing their process to comply with IEC62304 and creating the necessary deliverables to meet the software safety classes.


  • One single, process-oriented solution for all hazard, risk, requirement, verification, problem reporting and project artifact
  • Centralized and open repository for all artifacts
  • End-to-end traceability between the artifacts, for full impact analysis
  • Hazard Analysis and Risk Management
  • Requirements Quality enforcement