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.

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