We are Aligned, founded in 2006 by a team of individuals with extensive and international background in the Life Science Industry. Based in Zurich, Aligned AG covers one of the major European Life Science and Laboratory Automation clusters, located in Switzerland, the south of Germany and the French Rhône-Alp region.
Our clients are manufacturers, end-customers and sub-suppliers in the medical device industry, companies who develop and market products which are subjects to regulatory compliance such as FDA Quality Systems Regulations or the EU In Vitro Diagnostic Directives.
Our goal is to increase our customer's competence in how to successfully create quality compliant products through excellence in regulatory documentation.
What we do
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 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.