Aligned AG

Aligned AG provides the Medical Device ALM 'Aligned Elements for Design History File management. Aligned Elements is built to compile and manage your Design Controls by efficiently controlling a large number of individual but related design control items according to FDA QSR 820 and ISO 13485. Requirements, specifications, tests, risks, reviews and defects are all managed, traced and controlled in an efficient and transparent manner. Aligned Elements empowers you to keep your design history file complete and consistent during the entire project development process with minimal effort. Aligned Elements has been specifically developed with the particular regulatory requirements of the medica...