The complete Aligned Elements user manual available for download.

The reference document for the functionality, administration and configuration of Aligned Elements.

The Aligned Elements importer is used to import DHF content from existing Word, Excel, and CSV files such as requirement documents, specifications, and risk assessments.

This user manual describes the configuration options available for the Aligned Elements document importer.

Aligned Elements flexible reporting allows full flexibility in the look-and-feel of the Word output.

The reporting includes Design Items, trace tables, FMEA tables, risk summaries, and much more.

Some examples of applied reporting layouts are presented in this document.

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.

800 projects and 2500 documents in 20 months. How digital transformation in the pharma industry facilitate compliance with minimal effort.

Find out how Vetter Pharma digitalized their design, procurement and qualification process with Aligned Elements.

From scattered paper documents and time-consuming searches to streamlined, traceable, and audit-ready design control data. That's how MEGIN made the switch.

Discover how this neuroscience innovator replaced manual documentation with a ISO 13485 and ISO 14971 compliant solution.

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.

For more than 25 years, the pjur group has supplied the global market with medical and cosmetic products

Read more about how pjur uses Aligned Elements to manage their portfolio of devices in 70 countries.

Sony developed mSafety which combines a user-friendly wearable health/wellness device with a reliable back-end solution.

Read more about the development of mSafety and their reasoning for choosing Aligned Elements for Design Control Management.

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.