Aligned AG

Aligned (www.aligned.ch) provides 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.

At Aligned, we believe that management of product and project documentation of regulatory compliant products shall be efficient and pragmatic. We 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.

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.

Company’s Keywords:

design history file management, alm for medical devices, risk management, traceability matrix, medical device documentation