Requirements Management

User Needs, Design Inputs, and other Requirements are fundamental when compiling your Design History File / Technical File.

Tailor Aligned Elements to capture the data your QMS requires for Requirements and other Design Input/Output types. Editing, versioning, grouping, and tracing are accomplished with ease.

Use a single repository for all your requirements and ensure that there is never any doubt about the current state of your requirement catalogue.

All changes made, take place under strict version control, without letting the change management get in the way of your work.

A complete, chronological audit trail of all events is automatically kept during the project life cycle, demonstrating clear accountability and ensuring compliance with regulations such as ISO 13485 and FDA QSR 820.

Medical Device requirements management is a highly collaboration-intensive activity requiring close interaction between users.

In Aligned Elements, users gather input, discuss, review, approve, sign, and receive notifications about other users’ activity within the software. 

Use customized workflows to implement routing and responsibilities according to your own Quality Management System.

Workflows automate tasks, enforce controls and permissions, and notify users of assigned tasks and important events.

Gather and reuse Requirements from multiple sources and leverage your existing medical device requirements, created for MDR or QSR purposes, by easily transferring content into Aligned Elements.

Add Requirements in our rich-text forms, import existing design documents and electronic DHF data from Word, Excel, and xml, generate content and kick-start development from our preconfigured regulatory extensions, or copy items from your existing Aligned Elements projects.