Application Lifecycle Management
Aligned Elements
Technical File Management
Medical Devices - Faster
Document-centric DHF management is slow and error prone. Unlock the potential of data-driven Design Controls. Start your journey now.
Traceability driving design
Live traceability - at your fingertips
Eliminate manual merging and mapping across separate systems and rely on automatic traceability monitoring to drive out quality errors.
ISO 14971 Risk Management
Risk Assessment integrated at the core
Built for Medical Device development from the ground up with rich risk assessment capabilities as a core component from day one.
Integrates with your existing tool chain
Biotronik connects the dots
Streamlined Design Controls at Biotronik Vascular Intervention
From duplicated work, manual tracking and the looming risks of documentation inconsistencies to integrated, comprehensible Design Control Management.
Read more about how Biotronik streamlined their Design Control Management using Aligned Elements.
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!
