Why is Aligned Elements different?

Made By Med Tech People - For Med Tech People
Aligned Elements has been created by people with extensive experience in the Medical Device Industry. It has its origin in the needs of the daily work with Design History Files and strives to facilitate solve real, practical and regulatory problems facing the R&D, Quality and Management Departments in Medical Device Companies. It draws on extensive experience, accumulated knowledge and years of practical work with Design History Files and thus pays equal attention on the quality of the output and the easy-of-use in daily handling.

Focus on Relevance
Unlike other management tools, Aligned Elements does not focus on a specific or isolated part of the development process such as requirement management or test management. Aligned Elements starts with the Design History File as it is defined by the IVD-D or FDA QSR regulations and intends to generate a set of document artifacts that matches these regulatory requirements accordingly. Therefore, Aligned Elements does not only include management of requirements, specifications and test cases but also integrates activities such as Risk Analysis and Design Reviews.

Knowledge, Expertise and Experience
We know that a tool alone is not likely to solve all your DHF problems. Aligned Elements is only as effective as the plan, the intentions and the context in which it is implemented. Aligned therefore offers a number of complementary services to provide the best possible support to our customers. Each member of the Aligned Staff has previous experience as using and handling Design History Files tasks at Medical Device companies and consequently has the necessary understanding for the customers' work situation.