Why Aligned Elements?
Is your team held up by documentation work when it should innovate state-of-the-art medical devices?
Then you are not alone.
Medical Device companies report that up to 30% of the total development effort is spent on documentation activities.
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.
Maximal results, minimal effort
Aligned Elements integrates and traces all Design Control Items in your application lifecycle with full traceability into one single application, including:
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.
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.
Fast track to regulatory approval
By being built for Medical Device development from the ground up, Aligned Elements integrates support for many of the most central regulations and directives to the industry, including:
Integrated support for Risk Management, Design Reviews, DHF Index and Regulatory check lists makes Aligned Elements an exceptionally well-adapted choice for supporting the special needs of medical device development.