Develop Medical Devices - smarter and faster

Aligned Elements - the Medical Device ALM for efficient Design History File Management

  • Cut time spent on documentation
  • Free up valuable staff for innovation
  • Stay compliant with regulations


Complete control, unmatched transparency

Automatic change control is part of the regular workflow, ensuring a smooth daily use without obstructing the normal operations.

By tracking every change made to every Design Control Item throughout the project life time, Aligned Elements provides a complete and chronological audit trail of the entire Design History File.

Real-time assessments on the consistency and completeness of the DHF content can be made at any time, to uncover any faults and gaps, well in time before the auditor does.

googleplus facebook