Who Uses This Software?

Our clients work in the medical device industry and are regulated by norms such as the FDA QSR regulations in the USA or by the Medical Device / In Vitro Diagnostic Directives (IVD-D) in Europe.


Average Ratings

5 Reviews
  • 4.5 / 5
    Overall
  • 4 / 5
    Ease of Use
  • 5 / 5
    Customer Service

Product Details

  • Starting Price
    $480.00/year/user
  • Free Trial
    Yes
  • Deployment
    Cloud, SaaS, Web
    Installed - Windows
  • Training
    Documentation
    Live Online
    In Person
  • Support
    Business Hours

Vendor Details

  • Aligned
  • www.aligned.ch/
  • Founded 2007
  • Switzerland

About aligned elements

Is your team held up by documentation work when it should innovate state-of-the-art medical devices? Then you are not alone. Medical Device companies report that up to 30% of the total development effort is spent on documentation activities. Aligned Elements is the Medical Device ALM that helps you create, manage and trace the Design Control Items of your Design History File. By spending less time on regulatory documentation, you can free up valuable resources for innovation.


aligned elements Features

  • Administrator Level Control
  • Defect Tracking
  • Iteration Planning
  • Project Management
  • Release Management
  • Requirements Review
  • Task Management
  • Test Case Tracking
  • User Level Management
  • Version Control

aligned elements Reviews

Great tool with even greater support

Nov 06, 2015
4/5
Overall
4 / 5
Ease of Use
5 / 5
Customer Support

Comments: 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.

Feedback from a verification perspective

Nov 02, 2015
4/5
Overall
4 / 5
Ease of Use
5 / 5
Customer Support

Comments: 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.

Great tool for requirements management, risk management and easy traceability handling

Oct 22, 2015
5/5
Overall
4 / 5
Ease of Use
5 / 5
Customer Support

Comments: 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.

Highly recommended

Sep 23, 2015
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Comments: 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

Good tool for traceability and fast item access

Sep 22, 2015
4/5
Overall
4 / 5
Ease of Use
5 / 5
Customer Support

Comments: 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.