Amazing to see how adaptable AE is to our development process and risk management process, giving us the ability to work swiftly without any unnecessary constraints!

We have even integrated our automated test results in our system, and by leveraging that automated data in our traceability we can be even more efficient.

The configuration possibilities offered vast benefits. We have a very large freedom in configuring Aligned Elements according to our processes.

I can sincerely recommend Aligned Elements to any Medical Device company looking for a single tool to manage requirements, specifications, risks and design reviews.

Aligned Elements supports a structured way to, starting from requirements, create a traceable set of documentation through the whole lifecycle.

Thanks to the Linked projects-feature, we are able to reduce the duplication of module documentation to a minimum.

We benefitted by being able to create risk analyses for various product groups quite quickly and easily. We could now focus more on the content, and leave the form to the system.

Aligned Elements not only surpassed all other options but also inspired us, with their expertise and commitment, assuring them of the project’s feasibility.

The flexibility of the Aligned eQMS system has been a real game changer for us. Aligned Elements has significantly improved how we manage quality and design documentation.

Aligned Element have made life easy working with requirement/verification including traceability. We could easily make a structure suitable for us, for all our different products and their specifications.