User Needs, Design Inputs, and other Requirements are fundamental when setting up your MDR / IVDR / FDA QSR compliant Design History File / Technical File.

Aligned Elements adapts to your unique QMS and Development Process, allowing you any number of Requirement, Specification and Design Input/Output types with uniquely customized input forms.

Reporting and output styling is ready to match your company's corporate identity.

Change happens and that is expected.

Rely on the strict automatic change control in Aligned Elements, ensuring that all changes are correctly tracked and timestamped without getting in the way of your work.

A complete, chronological audit trail of all events is kept during the entire project life cycle, so you can demonstrate clear accountability and ensuring compliance with regulations such as ISO 13485, FDA QSR 820 and FDA QSR 21 CFR Part 11.

A single, secure, and continuously updated repository for all your requirements will eliminate any confusion about the current state and location of your Design Input content.

Medical Device requirements management is a highly collaborative effort, requiring close interaction between users.

In Aligned Elements, discussion and collaborate take place in real-time. Reviews, approvals, and sign-offs are communicated, assigned and coordinated efficiently, keeping your team up-to-date with automatic notifications and personal dashboards.

Let each team-member customize their experience by highlighting favourite requirements for fast access or subscribing to updates of critical items to remain up-to-date with important changes.  

Reach new levels of efficiency by intelligent re-use of your own Requirements and our existing Regulatory libraries.

• Extracting Requirements from legacy Word and Excel documents in your possession
• Re-using your carefully elicited, reviewed and approved Requirements, using copying / imports
• Connecting projects and re-use the same requirements in several contexts using referencing 
• Leveraging our large set of preconfigured regulatory requirement libraries
• Converting REQIF, XML or CSV files from external sources into native Aligned Elements Design Controls