aligned elements

Aligned Elements is the Medical Device ALM that helps you create, manage and trace the Design Control Items of your Design History File. By spending less time on regulatory documentation, you can free up valuable resources for innovation. Aligned Elements integrates and traces all Design Control Items in your application lifecycle with full traceability into one single application, including: • Requirements, specifications and use cases • Risks, Hazards and Mitigations • Verification and Validation tests • Design Reviews, Documents, Issues This not only eliminates the extra effort of manually merging and mapping information across separate systems but also provides excellent opportunity for automatic end-to-end consistency monitoring of your Design History File.