Aligned Elements
Aligned Elements Medical Device ALM delivers world-class 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.
Aligned provides Aligned Elements, an ALM system to ensure compliant development documentation for regulated products in the Medical Device Industry.
We assist our clients in developing, manufacture and market regulatory compliant products within shorter time-frames, to lower costs and with higher confidence.
At Aligned, we believe that management of product and project documentation of regulatory compliant products shall be efficient and pragmatic. We advocate an approach that allows your development team to focus on innovation instead of administration.
We strive to build value that last and therefore stay deeply involved with the undertakings of our clients until we are sure that sustainable results are achieved.