Extensions | Aligned Elements - the Medical Device ALM

The Aligned Elements IEC 62304 configuration

Getting compliant with IEC 62304 may seem daunting at first. The Aligned Elements IEC 62304 configuration has been set up to guide you through this process and has been tuned to automatically take care of most of the involved quality checks, making sure that the required tasks and actions are sufficiently covered.

The Aligned Elements IEC 62304 configurations contains:

  • Pre-configured templates using IEC 62304 standard naming conventions
  • Software Safety Classification automatically based on risk analysis results
  • Numerous quality checks for consistency verification
  • Pre-configured Reviews and checkpoints according to IEC 62304 stipulations
  • Pre-configured Trace Tables based on the IEC 62304 requirements
  • Included Process-checklists for documented verification of process compliance

The Aligned Elements IEC 62304 supports documentation management of:

  • System and Software Requirements
  • Software Architecture building blocks(Software Items, Units SOUPs and segregations)
  • Risk Management using a Preliminary Hazard Analysis technique (listed in ISO 14971)
  • Verification and Validation (Unit, Integration and System testing)
  • Change and configuration management (Problem Reports and Change Management)


Note! The Aligned Elements IEC 62304 configuration is significantly large extension to apply. 

To get the proper understanding of the extension aspects, we strongly recommend that you book a live demonstration of the Aligned Elements IEC 62304 configuration, please This email address is being protected from spambots. You need JavaScript enabled to view it.  to set up an appointment.

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