With the Aligned Elements V2.4 Service Pack 1 (2.4.132.12658) we have fixed a small number of bugs.
This service pack mainly addresses known problems with Word 2010 and Word 2007 from Aligned Elements V2.4.
It also provides fixes to the integration mechanisms with Countersoft Gemini and the usability of Test Runs.
If your team is using Word 2010 or Word 2007, you are recommended to upgrade to this service pack.
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We are proud to have our customers bring you Aligned Elements 2.4. This release includes some of the top voted features requested by the Aligned Elements user community. We hope you enjoy them!
Plan and Manage Verification and Validation Tests in Test Runs.
Get a full overview of Test development and immediate feedback on Test Progression.
Parallel Testing of Configurations
Assignment of Test Responsibilities
Test Run Progress Status Indicator
Apply tags to organize your Design Control Items by categories.
Activate Tag filtering in the GUI to work with the items that concern your current work.
Filter GUI on Tags
Perform Queries on Tags
Tag over multiple types and projects
Electronic Signatures can significantly streamline the signoff and release process.
Base on customer feedback we have added a host of new signing improvements.
Electronic signatures without Digital Certificates
Customize Signature location and page
Optional inclusion of Document Information
The Aligned Element Server can now be deployed in the Microsoft Azure Cloud.
Minimize your IT burden by using our hosted solution.
Minimize your IT Infrastructure
Aligned Elements configuration stored in secure cloud File storage
A faster way to get up and running
With more than 200 enhancements, fixes, and usability improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 here.
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A few years ago we could read articles claiming "Exoskeletons will one day replace wheelchairs". That the FDA regulates these kinds of devices is a clear sign that they are about to enter the mass market.
Miniaturization of electronics, a steep drop in manufacturing costs of mechatronic parts, increased computational power, more powerful batteries. A number of recent technical developments converge into the realization of exoskeletons growing nearer and nearer.
In this rapidly expanding field, competitors are scrambling to put their new models onto the market.
In the beginning of 2015 FDA announced that power exoskeletons will be classified as Class II devices with Special Controls, which clarified the regulatory situation for these kinds of wearable devices. Special controls have been put in place to address a number of risk factors identified by the FDA to be associated with the usage of powered exoskeletons.
For those used to medical device development, both the risks as well as the suggested requirements are straightforward. They include among other things, thermal and electric safety, biocompatibility, and the obvious risk of falling to the ground.
To help exoskeleton manufacturers getting up and running with their documentation, we provided the Aligned Elements Exoskeleton Extension Package containing:
This will give manufacturers a predefined starting point of setting up their Design History File with the intention of accelerating the documentation effort.
The Aligned Elements Exoskeleton Extension Package is downloadable here: Aligned Elements Exoskeleton Extension Package
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With the 2015 update of the IEC 62366-1:2015 and the issuing of the FDA Human Factor Guidance, usability engineering in medical device development has received increased attention recently.
Human factor analysis gets more important with the rising trend of offering patient-centric solutions via new mobile health applications and wearables.
When patients, rather than specialists become the medical device user, the increased focus needs to be placed on the patients' capabilities and the environment in which the device is used. IEC 62366-1 is applied in an effort to increase patient and user safety by identifying, assessing, and mitigating Use Errors, by paying attention to the usability of the device design and harness existing usability verification and validation methods to make sure that usability requirements are met and use errors are avoided.
For medical device manufacturers with limited previous experience in usability engineering, the task of implementing IEC 62366-1 might seem intimidating. However, the updated 2015 version of the standard has simplified and clarified the required process steps and tasks and Aligned Element now features a preconfigured setup that integrates the inputs, outputs, and risk-relevant elements of the usability process into the overall Design Control traceability.
The configuration includes:
On top of all that, the Aligned Elements IEC 62366 includes all the standard features of Aligned Elements, including:
By applying selected parts of the Aligned Elements IEC 62366-1 configuration to your Aligned Elements setup, you can efficiently leverage Aligned Elements in your IEC 62366-1 compliance effort.
The Aligned Elements IEC 62366 configuration is available for download in our extension library.
For a live demonstration of the Aligned Elements IEC 62366 configuration, please
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2016 seems to become the year when it all comes together. The traditional domination of hardware and pharmaceuticals is being caught up by health-through-information.
With wearables becoming a commodity, the 5G standard approaching fast, enabling a revolution in IoT communication, health apps, electronic handling of prescriptions, and patient dossiers, health becomes more and more about collecting, analyzing, and acting on data.
The digitization of medical device products will have a profound effect on the way the industry conducts business and generates growth.
However, according to McKinsey, medical device companies have been slow to adopt, not necessarily when it comes to what they produce but rather how they produce it. I am often surprised to see how the digitization of the medical devices themselves rarely is matched by an equal digitization level of the development processes.
Ironically, the medical device industry, with its well-known dilemma of being required to provide high-quality innovative products in a regulated market is an exceptionally good candidate for process digitization.
The documentation requirements on a medical device manufacturer are both growing and changing, forcing the development effort to become increasingly focused on the paper trail.
For safety reasons, compliance rightfully requires each step and decision to be carefully recorded. Even though being a just and fair requirement, the operational reality of such a process unrelentingly divides the attention of a professional R&D workforce from innovation to administration. A traditional paper-based approach is simply not up to the task of managing the interconnected nature of the DHF.
Digitizing the development documentation process and rely on a unified repository for the design history file management will not only increase the efficiency of the work and free up valuable innovators from menial documentation tasks. It also makes it possible to automatically analyze and verify the completeness and consistency of the DHF artifacts, increasing the quality of output.
With a medical device ALM like Aligned Elements, allowing the digitization of work practices and document handling, the medical device manufacturer will match the innovation of his products with the efficiency of his processes.
Aligned Elements supports facilitating capabilities like:
Read more about Aligned Elements here.
This release brings a host of performance improvements, making Aligned Elements data load faster and make your day-to-day work a lot smoother. Quicker loading of the Trace Explorer content and Project explorer books will allow you to concentrate on the more important tasks at hand.
Use drag and drop to add images and files to the Rich Text and Table attributes. Use menu quick links to add symbols to your texts. Use key-combinations to get your preferred AE hyperlink content. Fewer clicks to accomplish your daily documentation tasks.
List your pending signature tasks with a single click. Electronically sign single or multiple documents with a simple point and click.
With more than 60 enhancements, fixes, and usability improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.3 Service Pack 5 here.
With the Hotfix Aligned Elements V2.3 Service Pack 4 (2.3.52.11241) we have fixed a small number of bugs.
Note that these issues do not pose any danger to the data integrity of the projects. It is only a matter of fixing performance and usability issues that have a negative impact on the Aligned Elements user experience.
If you don't have the required skills and resources for installing and managing your own IT infrastructure and software, consider using Aligned Elements' cloud option. With a cloud option, you can get up and running quickly while simultaneously keep down costs for IT infrastructure and reduce deployment risk.
Create and update Word reports even faster. Generate template-based Word reports on-the-fly with customized look and feel, create and populate Word documents with two simple clicks or update your documents with the latest database changes without even opening Word!
Collecting document signatures is a final mandatory step when compiling medical device development documentation. A simple but often tedious action since finding the right signees at the right time can be a challenge in today's dynamic environment. Use Aligned Elements e-signatures to send e-signature invitations to the signees. They are just two clicks away from completing their signature.
With more than 100 enhancements, fixes, and usability improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.3 Service Pack 3 here.
The "IEC 62304 – medical device software – software life cycle processes" is a standard specifying life cycle requirements for the development of medical software and software within medical devices.
This international standard is harmonized by the EU and USA and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.
Software development according to IEC 62304 is a risk-driven approach, requiring the developer to perform reliability- and safety-enhancing actions and tasks proportional to the risk the software pose to the patients and users.
Getting compliant with IEC 62304 may seem daunting at first. The Aligned Elements IEC 62304 configuration has been set up to guide you through this process and has been tuned to automatically take care of most of the involved quality checks, making sure that the required tasks and actions are sufficiently covered.
The Aligned Elements IEC 62304 configurations contain:
The Aligned Elements IEC 62304 supports documentation management of:
On top of all that, the Aligned Elements IEC 62304 includes all the standard features of Aligned Elements, including:
By applying selected parts of the Aligned Elements IEC 62304 configuration to your Aligned Elements setup, you can efficiently leverage Aligned Elements in your IEC 62304 compliance effort.
The Aligned Elements IEC 62304 configuration is available for download in our extension library.
For a live demonstration of the Aligned Elements IEC 62304 configuration, please
Automatically push updated, synchronized, and released DHF documents from Aligned Elements into your Document Management System. Aligned Elements workflow actions push documents from Aligned Elements to a designated file location of your choosing. The push action includes optional PDF conversion, dynamic file name strategies, and transfer of document metadata.
Create and assign bugs and deviations to individual test points/test rows without having to leave the testing context. Seamlessly use your existing issue tracking system, be it TFS, JIRA, Trac, or Gemini, from inside Aligned Elements' test execution environment.
Use the Aligned Elements specific URL:s to reference Aligned Elements Document Objects outside the application. The URL is a clickable link that can be used in emails, on the web, or in Office documents to designate individual Aligned Elements Document Objects. Click on the link to automatically open the Document Object in Aligned Elements.
With more than 130 enhancements, fixes, and usability improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.3 Service Pack 2 here.
