Aligned Elements Medical Device ALM delivers worldclass Design Control Management to accelerate your Technical File / Design History File completion.

Built for Medical Device development from the ground up, Aligned Elements supports industry standards regulations such as MDR/IVDR, ISO 13485, ISO 14971 and FDA QSR 820 out-of-the-box.

Aligned Elements provides seamless design control traceability, integrates risk assessment, as well as verification, and validation activities, essential for completing the TD/DHF.

The result is a complete, correct and consistent technical documentation, enabling rapid approvals and an accelerated market access.

We are driven by a singular purpose; to accelerate the development of cutting-edge medical devices while freeing up time for innovation, instead of administration.