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.
Many of our clients develop and manage medical products, regulated by norms such as the FDA QSR regulations in the USA or by the In Vitro Diagnostic Directives (IVD-D) in Europe. It is the special needs and circumstances which drive such projects that also shape our own portfolio.