Aligned Elements, an Application Lifecycle Management (ALM) software for Medical Device development. They assist their clients in developing, manufacture and market regulatory compliant products within shorter timeframes, to lower costs and with higher confidence. At Aligned, they believe that management of product and project documentation of regulatory compliant products shall be efficient and pragmatic. They advocate an apporach that allows your development team to focus on innovation instead of administration. Many of 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.Aligned Elements, an Application Lifecycle Management (ALM) software for Medical Device development. We assist our clients in developing, manufacture and market regulatory compliant products within shorter timeframes, to lower costs and with higher confidence.
“We investigated the relevant standards and made decisions on the level of compliance we needed, We then looked for a tool specially designed for the quality and lifecycle requirements defined by the relevant standards that could facilitate the creation of documentation and lifecycle management.”
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