Aligned Elements V3.1 (3.1.547/272.24402) is here, and we are proud to includes a large set of new features and fixes.

What's New

V3.1 is a large update, and we introduce a host of new features in this one.

Get the full story on some of the new features in Aligned Elements V3.1 below:

• AI Supported Design Control Management
• New UI Improvements
• Upgraded Query Engine
• 10 more reasons to love AE V3.1

The Release Notes containing all new features and fixes can be found here.

Sign up to the "What's New" Webinar on Thursday April 3rd

Curious to see the new features live?

Want to gain a deeper insight into what Aligned Elements V3.1 can do for you?

Register today to the "What's New" Webinar

When: Thursday, April 3rd, 2025

Time: 14:00 CET (45 Min)

Use this link to Sign up

Upgrade Now

This release is a recommended upgrade.
Find the installer to Aligned Elements V3.1 here.

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We are proud to present Aligned Elements V3.1, that includes:

• AI Supported Design Control Management
• New UI Improvements
• Upgraded Query Engine
• 10 more reasons to love AE V3.1

If you are interested in an in-depth demonstration of Aligned Elements, contact us on This email address is being protected from spambots. You need JavaScript enabled to view it..

The webinar can be viewed below:

Enjoy!

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We are just days from releasing Aligned Elements V3.1, and we are truly excited about all the new features being made available to Aligned Elements Users.

We have already talked extensively about the new AI Features, new UI improvements and an enhanced Search/Query experience.  But there is even more in the Easter Bunny's bag this year!

Join us in our "What's new in Aligned Elements V3.1" live webinar on Thursday April 3rd 14:00 CET for an in-depth walk through of all new features and changed.

Sign up here: Registration Form 

Here are 10 more excellent reasons to upgrade to Aligned Elements V3.1 and make your Technical File complete, correct and consistent at a higher tempo and with less effort.

1. All Tasks in all Projects in One View

Would you like to see all your assigned Tasks across all Projects? This is what the Project Overview is all about! All projects listed, in a single view with all your open tasks, upfront, at your fingertips with a single click. 

2. ReqIf Import Support

Requirements Interchange Format (ReqIF) defines such an open, non-proprietary exchange format and is supported by many requirement management and ALM tools. Our Aligned Elements Importer is now compatible with the ReqIF format, and ReqIF data can now be converted and imported into your Aligned Elements projects. 

3. Show previous Test Results In Test Run

First things first. When starting a new Test Run, it makes sense to start out with previously failed tests to make sure they are fixed in the newest version of your device. The result from the previous execution can now optionally be displayed in the Test Run to assist you in doing the optimal prioritization of your tests to run.

4. Create Unique Test results per Test Run

Need more flexibility in keeping your Test Results apart? With a simple configuration change, unique Test Results can now be created per Test Case - Configuration - Test Run combination. 

5. Linked Project Overview / Show linked traces in child projects

Which 'parent' projects are linking/using this project? The answer can now be found in the Linked Project View in Manage Projects. Furthermore, you can now open a child project and see linked traces in the Trace To and Trace From tabs from all 'parent' projects.  

6. Probability in Harms

More on the medical device ìndustry's most flexible Risk Management: several Aligned Elements customers have requested the possibility to define not only the Severity in the Harm object but also the Probability of Occurrence of Harm. Grouping these two parameters in the Harm is now optionally available in Aligned Elements V3.1.

7. Email users from Manage Users

Planning a maintenance? Want to inform about a template change? Need to communicate urgently with your Aligned Elements user base? Use the Email Users function in Manage Users to reach all your Aligned Elements users with a single email.  

8. Include Comments in Excel Export

The nested/threaded comments is a much revered feature, making online collaboration truly happening. We expand on that feature with our previously mentioned search-by-query option in Comments and now also, including the exporting of comments to our Excel Reports from the Chapter View.

9. Reset Review Assessments on Change

More on Design Reviews: a new optional behavior is to reset existing Review assessments when an object under review is modified. This supports the review scenario: assess => modify => re-assess. Reviewers are automatically notified via email if an assessed object under review has been changed and a re-assessment is expected 

10. Performance Improvements

Aligned Elements V3.1 brings performance enhancements in several areas, including Review management, Query management and Chapter management. This will decrease load times on frequently performed functions and improve the user experience, enabling faster operations and get you to a complete Technical File as rapidly as possible. 

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By popular request, we have expanded the capabilities of our query engine even further, adding to the already massive set of search capabilities and strengthening the ease-of-use.

This new set of improvements provides the most powerful and flexible way to find exactly the data you need.

'OR' - Filters

The possibility to create union filter combinations, or simply 'OR'-filters, has long been at the top of our users wish list. With Aligned Elements V3.1, we introduce the possibility to create 'OR'-combinations between the most important filters, taking the first step in this direction. You can now filter your data with several filters/conditions, where only one of the conditions need to be satisfied to yield a result.

Three new Query Filter Types

To achieve the best relevance of results, we have added three more filter types, expanding the number of available filters to 18!

The new Query Type filters are:

• Approval Attribute Filter - find items using electronically approved Approval Attributes, that have not been approved, have been approved by a particular person, for a particular reason for before or after a particular time.
• Comments Filter - search for items having comments that are not yet resolved or declined, written by a particular author or was created during a particular period.
• "Item State In Test" Filter - unveil tests that have either been or not been assigned to a particular person, and test that have been executed or not

Overhauled Query Designer and more easy-of-use

Adding all these new Query improvements called for a restructuring of the Query list and Query Designer.

In the revamped UI, you will now find:

Searching-as-you-type filter
Find your query faster by using the search-as-you-type filter at the top of the Query list.

Help texts in the Query Designer
Clearer information are now found next to the major query options, provided by hover-popup help texts.

Copy Query
The new Copy button lets you duplicate existing queries effortlessly, saving time and ensuring consistency. Say goodbye to tedious reconfiguration — just copy, tweak, and get instant results!

Lock items in the query output
Added to the many existing Action options, you'll now find the new "Lock Objects" which lets you swiftly lock down the Design Controls yielded by your query.

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After nine months of development, we are excited to introduce the latest version of Aligned Elements. This update brings a sleek and improved UI, along with a range of usability enhancements designed to make your design control and risk management processes smoother than ever.

We know that efficiency is key for medical device professionals navigating complex regulatory requirements. That’s why we’ve focused on making Aligned Elements faster, more intuitive, and easier to use in this release - so you can spend less time managing documentation and more time driving innovation.

Here are some UI highlights in this new release:

Compact Form Layout

For attribute-rich Design controls, this new, optional display-style provides a clearer and more compact display of your data. The Compact Form option puts attributes side-by-side, with up to four attributes being placed on a single row.

Your important information becomes immediately visible with less need for scrolling! 

Above we see a comparison of identical data, in this case a Test Result, using the Classic Layout to the left and the Compact Form Layout to the right. As you can see, the Attribute name/label is display above the control instead of to the left. This makes it possible to maximize the use of horizontal space, which comes in very handy for e.g. Table Attributes and Traced Object Attributes.

We also introduce collapsible subsections. You now group attributes in themes or topics and place them into sections that can be expanded or collapsed by the user.

Introducing optional fixed width on selected column in Table Attributes allows optimized use of screen space. Make Checkbox and Dropdown columns narrow and free up horizontal space for descriptive columns instead.

Improved side-by-side scrolling in the Main View

A much wanted feature is the independent scrolling of the Chapter List (on the left side of the main view), and the Design Controls Tabs (on the right side of the view). The scrolling of these two sections can now be done independently.

As a consequence, we have also moved the Tags and the Positive Cues from the top of the main view, to the top of the Chapter View. The much more space-saving Tag bar now only displays tags applicable to the current type. We end up with a cleaner and more user-friendly layout. 

Introducing Trace Lists

Traceability is a cornerstone in Medical Device Design Control Management and Technical Documentation creation. It helps us to verify our Design Control structure is complete, correct and consistent. Aligned Elements makes intense use of traceability, leveraging this information as much as possible in order to deliver insights and solutions to Design Control problems.

Traces are always displays at the bottom of each Design Control form in the 'Trace From' and 'Trace To' tabs of the Detail View section. However, it is sometimes beneficial to show a curated selection of incoming or outgoing traces directly in the form. For this purpose, we introduce Trace Lists. Trace Lists can be used to provide important context by displaying trace information in the form itself.

In the example above, the referred Hazard is displayed at the top of a Hazard Analysis item to provide context to the Risk Assessment being carried out.

Trace Lists are added via configuration and does not implicate a revision change.        

And much more!

These are three examples of UI improvements in Aligned Elements V3.1 but there are of course many, many other features included as well. We'll introduce multi-column filtering in grids, adding / removing individual values to multi-select attributes using 'Update Multiple Items', emailing to e.g. currently logged in users in 'Manage Users', search-as-you-type filters as standard in dropdown and multi-select lists and many, many more things.

To find out more about the new things in Aligned Elements V3.1, sign up to the "What's New in Aligned Elements V3.1" online seminar broadcasted on April 3rd.

Over the last 6 months, we’ve been investigating how using AI can make Aligned Elements faster, more efficient and more helpful.

Now, three new AI features for better Design Control management are being placed to your fingertips. We’re making it easier to create test cases, to locate the best traces, and to write distinct item titles and for your design control.

Automatic writing of Test Cases

Our new feature introduces an AI-driven approach to automatically populate test case attributes, including test steps, based on the traced requirements and specifications. By creating an instance draft of a test case, the test engineer can then analyse and refine the suggested test case content.

This method reduces the manual effort involved in test case authoring and enables your team to focus on other critical aspects of development. With a balanced approach of AI automation and human precision, we offer a pragmatic solution to modern quality assurance challenges.

Let AI suggest the best traces

When large Design Controls set find themselves in constant flux, where items are added, removed and modified, it is not easy to know if the current traces are the correct ones.
It is simply not possible to keep all the items in your head, and elaborate searching is needed to make sure that all traced items have been correctly identified.

With AI-powered assistance, Aligned Elements analyses the entire list of potential trace candidates, compares the current design control with the content of the list and automatically suggests the best matching traces. Using our "AI powered-human driven", the user has the final say in deciding whether the suggestions are correct and ultimately sets the traces. This functionality not only assist when setting new traces but also provides a robust mechanism for cross-checking and validating existing ones.

Create a summarized title with a single click

All Aligned Elements Design Controls require a title that epitomizes what the Design Control is about. The title is also the primary text displayed in Design Control lists, and thus serves as your visual cue for the item. It is not always obvious how to summarize an elaborate Design Control in the best possible way.

Here, again, AI comes to rescue. Our last feature is built to automatically write a short and snappy title that accurately describes the Design Control. With a single click, the AI analyses the Design Control content (you, of course, decides which aspects the AI shall consider) and automatically populates the title field with a summarized text.  

How can I get these features in my Aligned Elements?

These features (which are supported exclusively by the Aligned Elements Web Client) are available in our upcoming release Aligned Elements V3.1 with a planned released on March 31st 2025. The first step is thus to upgrade to this version of Aligned Elements. All three features are switched off by default and only becomes available when explicitly added through configuration, each one configured separately.

Contact your Aligned representative for more information, on how to conduct trials with your own data and assistance on how to make the configuration changes. 
Note that Aligned Elements AI features may incur additional costs.

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Do you make medical devices?

If yes, you’re likely familiar with the technical documentation challenges that come with the territory.

We provide an excellent system to help you overcome those challenges.

"But how do I know that such a system won’t disrupt my processes?"

Good question!

You are the expert on your product and your organization. You’ve invested considerable effort in refining your processes and templates to optimize your work. The last thing you need is a tool that forces you to rework everything.

Not Aligned Elements.

Where other tools impose limitations that require substantial changes to your QMS, Aligned Elements adapts to your needs. From the start, we recognized that each medical device manufacturer operates with a unique set of SOPs, processes, and templates, carefully developed to suit their specific requirements. That’s why we designed Aligned Elements to be flexible—so it can reflect your processes, use your document templates, and present your terms and notions in the UI.

This results in higher user acceptance, a lower learning curve, a shorter adoption process, and reduced implementation risks.

How Aligned Elements Adapts to Your Needs

Design Control Naming and Traceability

We begin by identifying all your Design Control types and their expected traceability. We then ensure that each type includes exactly the data specified in your SOPs and templates. This significantly accelerates adoption, as your users will immediately recognize familiar terminology and structures.

Trace Reporting

Our built-in Trace Table Designer allows you to create customized trace tables and matrices on the fly. Simply generate a trace table, inspect the results, modify the design, and rerun it within seconds. These traceability matrices can be exported into Word documents that maintain your unique corporate design.

Tailored Risk Assessments

While ISO 14971 provides a standardized framework, we have found that risk assessments vary widely between organizations. Among the hundreds of medical device manufacturers we’ve worked with, each has had its own approach to risk assessment.

To accommodate this, we designed the Aligned Elements Risk Assessment section to be the most adaptable in the industry—and we continue to expand its capabilities.

Creating Technical Documents

Your QMS already includes tried-and-tested document templates—why not use them in Aligned Elements? Documents generated by Aligned Elements adopt the styling and structure of your existing templates while seamlessly integrating Design Control content.

You can mix and match structured data with anything created in MS Word, ensuring you get the best of both worlds. For maximum flexibility, Aligned Elements supports different Word styles for different contexts, such as formal styles for official documents and informal styles for internal reviews—giving you complete control.

Seamless Integration with Your Existing Toolset

Aligned Elements is explicitly process-independent, offering high flexibility in naming conventions and reporting formats to fit seamlessly into your workflow. It integrates with existing tools such as defect tracking systems (GIT, Atlassian Jira, Azure DevOps, Redmine, Trac, etc.), enhancing their capabilities with consistency checks, traceability, and reporting features.

What About Cost and Implementation Time?

We help every customer set up Aligned Elements according to their specific needs. This process typically takes only a few days. You can find pricing details [here].

Are You Forever Dependent on Our Expertise?

Absolutely not. As an Aligned Elements customer, you own your configuration. You can access and modify it at any time.

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Aligned Elements V3.0 Service Pack 1 (3.0.447/231.22672) is released.

What's New

V3.0 Service Pack 1 contains a number of important fixes for Aligned Elements V3.0.

The Release Notes describing the fixes can be found here.

Upgrade Now

This release is a recommended upgrade.
Find the installer to Aligned Elements V3.0 Service Pack 1 here.

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We are proud to present Aligned Elements V3.0, that includes:

• Released Document View
• Generate and Autopopulate Documents
• An upgraded Review Experience
• More than 250 new features and fixes

If you are interested in an in-depth demonstration of Aligned Elements, contact us on This email address is being protected from spambots. You need JavaScript enabled to view it..

The webinar can be viewed below:

Enjoy!