We use Aligned for both risk management (dFMEA 60812 and risk analysis 14971) and requirements management. It is a no nonsense tool, with a good support team, customizable and easy to use.

Easy requirement tracing, good trace table creation possibility, quick and personal support from Aligned when you have a problem, possibility to get templates from Aligned and/or create/adapt them yourself (if needed with their help via a video chat). I really like the personal support and the ease of use and tweakability.

If you encounter an issue they are very willing to help. They can have a look with you really fast and if the problem requires an Aligned issue, they really want to improve their tool.

Aligned Elements is so helpful to us in enabling containment of the design and development process. The team @ Aligned are also incredibly receptive to our requests for customisation, and also always quick to act whenever we have issues or bugs.

I really like the organisation which Aligned Elements provides. The ability to link together all items from your business needs and user needs, all the way through the design & development process, including your hazard analysis, verification & validation, will really help when it comes to performing a regulatory submission. With all of the key information being traced, change controlled, and managed in the same space, it is easy to follow the design process from start to finish.

I feel there is definitely room to improve in terms of automating some tasks. It would be helpful to have the ability to set up reminder emails with a frequency for tasks which require completion. When adding tables within areas like a Verification test case, having the ability to set the width of columns would be helpful, as sometimes we have found that the visual aspects of a page can get a bit unwieldy, and side scrolling of a page then becomes necessary.

The product helps a lot to better adhere to processes. Secondly, missing items / traces / reviews are identified with 1 click. It improves efficiency during the life cycle mgmt of a product compared to manual paper work. Even if not used every day, it is intuitive to use.

Easy to use. Great user support. Easy configurable for client's needs. Big plus: risk management included compared to other tools. Thus, traceability is easy among the artifacts.

Sometimes, 2 AE windows next to each other would be useful to work efficiently -> work around with Word export. Need to log off / on again sometimes due to bugs.

It took me a long time to feel comfortable with the software but now that I know how to use it, I like it. However, until the complete development team is not using it in their daily work, we will not use all the functionalities of the software such collaboration or prioritization.

I like that the structure of our documentation is directly reflected inside left menu and that this can be customized depending on processes the project needs to follow. This is helping to work according to our processes.

Not so user friendly even if this was improved a lot the last 2 years. It is hard to remember how to use the software when it is only for sporadic use, a bit more guidance from the software would be helpful.

Document generation is sooo cool !

The Support Team : they are doing a GREAT job !

Queries should be more flexible, more powerful. Same for widgets. Widgets should be able to display the results of complex queries.The User Interface is difficult to grasp at the beginning.Need at least 1 to 2 weeks to understand how it is organized.

Needs some time to get warm with it, but as soon as you are its working well!

Integrates a lot of functions to ensure an accurate development file and to track Requirements

Hard to setup and the Usability during daily use is due to the Database like workflow some times difficult

AE was good enough to adapt to our development process and risk management process. Content traceability and content control from AE is always appreciated.

Good adaptability with processes, Good content control, and Good traceability of the document objects especially in case of Linked Projects

Poor team collaboration as well as limitations in the adaptation of the AE with other tools

Using it also for non-medical products. Wherever good requirements management is important, I would recommend Aligned.

- Requirements management- Risk management- Tracing- Collaboration- Ease of use- Principle / architecture of the system- Tracking changes

ReviewsConfiguration management, especially tracing of verification to certain versions of the product

Excellent support in case of questions and issues. I always got a solution!

Constency is always assured even in complex projects. Risk management is flexible and reliable.

It's a complex project. Setup, configuration and learning to handle it takes a while.

This tool is used in our company to support the product development from the design analysis through the system/software requirements to the test cases. Furthermore it provides an integrated risk management module to connect the risk analysis points directly and easily with effected requirements and vice versa. One of the tool benefits is a huge reduce of spent time to create, update and manage several document inputs and the documents itself! Furthermore the tool provides a plenty of possibilities to customize it for the own required purpose.

I have been using Aligned Elements for a few years now in different projects and one of the I like most is the flexibility/customizability of the software, so you can easily adjust it to fit your processes, templates and needs. As with every piece of software you encounter once in a while a problem, but in these cases the guys from Aligned are there within no time to resolve your issue. All in all, aligned has been an excelent experience for me so far.

Very good tool for requirements engineering, very very easy to use, lots of possibilities to create documents/ tracetables with a few clicks. Perfect for medical industry. Fast and professional customer service

I used the tool for test case plan/report development and overall test plan/report. The tool is simple of use and the navigation between different project items fast and comfortable thanks to its multiple-level traceability. The text editor as well as the export functions suffered some inconveniences but the support / owner team was listening to user feedbacks with high availability, which means the tool can be customized as needed.

Very nice functions to help keeping the overview and know the audit readyness of your (medical device) product like consistency check and many more with very low documentation-wise effort.