Aligned eQMS
A Digital QMS Approach
Does compliance slow you down?
Paper-based Quality Management is an efficiency killer. Ditch & switch to the Aligned eQMS for streamlined processes and enhanced regulatory readiness.
Bring people and information together
From concept to customer
The digital way, designed for the usability, collaboration and flexibility of modern organizations. Use a purpose-built medical device eQMS and get your devices on the market faster.
Kickstart your work
Why start from a blank page?
With 31 SOP:s and more than 100 templates carefully crafted for FDA QSR 820 and ISO 13485:2016 compliance, your journey to market access starts right here.
Focus Re-Innovating Quality
Innovation Without Disruption - Focus on Quality Management
Discover how Focus streamlined its quality workflows, reduced manual effort, and strengthened compliance with a unified approach to documentation and design control.
Explore how Focus used the Aligned eQMS to bring faster project delivery and built a scalable foundation for future growth.
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.
Andrea Paulus
Thanks to the Linked projects-feature, we are able to reduce the duplication of module documentation to a minimum.
Christoph Karthaus
I can sincerely recommend Aligned Elements to any Medical Device company looking for a single tool to manage requirements, specifications, risks and design reviews.
Victor Steinacher
Aligned Elements supports a structured way to, starting from requirements, create a traceable set of documentation through the whole lifecycle.
Claes Nilsson
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.
Anna Norlander
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!
