IEC 62304 Checklist for Software Audits


If you develop software for a medical device then you have hopefully aligned your processes with IEC 62304 - Medical Device Software.

In an auditing situation, you might be required to demonstrate how you comply to this standard.

We give you a fast and trackable way to do just that!

Our IEC 62304 Checklist is integrated in Aligned Elements and lets you perform the assessment inside AE, taking advantage of inconsistency rules, tracing to existing project documents as objective evidence and simple export to word once completed.

The checklist includes 93 prepared audit questions based on the requirements in IEC 62304.

This is a simple and efficient way to demonstrate your company and software's compliance with the standard.

Download it here.


Webinar: New in Aligned Elements V2.5 SP 4


In this recent New in Aligned Elements V2.5 SP 4 Webinar we presented news and improvements including:

  • A new UX experience
  • Enhanced Review and Feedback Options
  • Highlighting Inconsistent Items in Word Documents
  • Integration with GitLab and SVN
  • Centralized User Management

...and much more.

The recording is available below. 



Using Aligned Elements to trace to Source Code in a Subversion Repository

In many products, software is an important component of medical devices. With increasing demands for greater functionality within medical devices, the complexity of medical device software development also increases. This, therefore, places increased demands for appropriate traceability.

With Aligned Element V 2.5 SP 4, it is now possible to directly connect to your Subversion Repository.

This connection can be added as an additional field to any existing type.

A typical scenario for this would be to specify a specific check-in when closing an Issue. It is also possible to create a completely new type, for example, a “Source Code Item”. This type can then be included in the traceability landscape of your project.

Furthermore, the displayed source code files can be filtered by their file extension.

These features will allow you to:

  • Maintain traces between requirements, UML designs, test cases, and their associated source code.
  • Trace from Source Code to associated tests or reviews.
  • Through Inconsistency Rules, find out which UML designs or requirements have not been implemented yet.
  • When closing an issue, you can document in which SVN check-in the Issue has been addressed.
  • Easily create trace tables from any object to Source Code.
  • In reports, in addition to the name of the source code file, display the actual source code.

If you are interested in adding the Subversion Integration to your Aligned Elements project, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

Aligned Elements V2.5 SP 4 released

What's New


Aligned Elements V2.5 Service Pack 4 (2.5.344/120.17963) is here and includes some awesome new features and a host of bugfixes


Web Client UX Overhaul

A host of new UX features and an updated color scheme makes the use of Aligned Elements an even more efficient and pleasurable experience.



New Design Review Experience 

Let each Review Team members inspect and provide feedback on Items under Review, aided by great analytics and feedback capabilities.



Highlight Inconsistent Items in Word

For easier inspection and faster reviews, automatically highlight inconsistent items in word documents to quickly visualize and address outstanding issues.



What's Changed

  • Integration with Subversion
  • Integration with GitLab
  • Configurable Email content
  • Update Fonts in items with Batch Change
  • Replace Words in items with Batch Change
  • Queries for External Issue items
  • Automatic Change Comments
  • New Inconsistency Rule: check for unreviewed items in Documents
  • New Inconsistency Rule: item must exist in signed Document
  • Warn when trying to edit item currently under Review
  • Group Attributes in Form
  • New Approval Attribute
  • Risk Summary Widget in Dashboard
  • Centralizing User Management in Web

Upgrade now

With exciting new features and important fixes, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.5 SP 4 here.

The IMDRF terminologies - a common risk language


Have you ever struggled to describe Hazardous Situations so it was clear to all stakeholders what you intended to say?

Did you spend a lot of time to come up with a concisely written Sequence of Events and then the first person to review your document claims to not understand what you intended to convey?

When describing your harms, have you ever wished that someone had put together a list of all possible harms, so you could just pick the one, which is applicable for this particular situation?

And then after your product release, did a Risk occur that you did not foresee?

Common Terminology by curtesy of the IMDRF

If you have ever experienced one or more of the above, there might be some help out there. The International Medical Device Regulators Forum ( has created a document called IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure, and codes.

Although that is quite a mouthful, this document can make your life a lot easier. It provides an extensive list of possible medical device problems, possible harms, and related causes. Each term is assigned a code, which has to be used when creating a Manufacturer Incident Report as required by the MDR (

These codes can also be used when reporting Adverse Events to the FDA by means of a Medical Device Report (

Is the terminology only applicable for post-market events?

Although the terms compiled by the IMDRF have a strong focus on Post Market incidents, they are also useful in your pre-market design risk assessments. When performing your ISO 14971 compliant Risk Analysis during the development phase, a lot of time is (and should be) spent on the risk identification process to make sure all potential risks have been assessed and addressed.

In practice, this requires writing down and assessing the hazardous situations, what causes, and subsequent harms that could possibly arise by using your product. However, these are essentially the same as in a post-market scenario. Using the lists provided by IMDRF can speed up this process significantly.

So how does this make things easier for me?

The IMDRF lists act as an acceleration vehicle for your Risk Analysis. By using and analysing these established terms, you will save a significant amount of time when documenting all possible hazardous situations, causes, and harms. At the same time, the likelihood of overlooking a particularly hazardous situation, cause, or harm is greatly reduced.

Furthermore, ambiguities are reduced by using and referring to an established set of risk terminologies. Thus, you reduce the risk that other stakeholders, not just your colleagues, but also the auditors, will not misunderstand your carefully constructed Risk Analysis.

Using the IMDRF terminology in Aligned Elements

The lists are applicable to Aligned Elements projects using Risk Assessments using the Preliminary Hazard Analysis method. 

It is possible to import the IMDRF items directly into Aligned Elements by using four import packages which you can download here.

The extension consists of lists containing a Design Control type called “IMDRF Item”, which have the attributes “Code” and “Definition”.

When importing them, you will need to map the types to types that exist in your configuration.

Note that the lists contain a large number of items that may not all be applicable to your particular device.

A pre-assessment step of the list content is therefore recommended before applying them to production projects.

The following mappings should be done.

  • “Annex A, Medical Device Problems” (469 items) should be mapped to a type that represents “Potential Hazards” in your configuration.
  • “Annex D, Investigation Conclusions” (35 items) should be mapped to a type that represents “Causes” in your configuration.
  • “Annex E, Health Effects - Clinical Signs and Symptoms or Conditions” (797 items) should be mapped to a type that represents “Harms” in your configuration.
  • “Annex F, Health Effects - Health Impacts” (64 items) should be mapped to a type that represents “Harms” in your configuration.

Please do not hesitate to ask for assistance at This email address is being protected from spambots. You need JavaScript enabled to view it..



Identifying Risks using ISO 14971:2012 Annex C

Risk Identification is an early and essential part of the risk management process and ISO 14971 requires us to make a complete risk assessment, to identify ALL hazards. 

But, how do we know if all of the hazards have been identified? How can we prove this?

You could brainstorm or have a whiteboard session gathering ideas that pop up, but the only way to truly achieve confidence in your risk identification process is by using a structured approach. 

There are several techniques available depending on the assessed source, including:

  • Assessing established potential hazards from internal records or published standards
  • Analysis of the manufacturer's experience with similar medical devices
  • Conducting a User Task Analysis on the user’s interaction with the device to uncover use errors
  • Assessing Field data and published incidents from similar devices in use
  • Assessing critical components for safe and effective use

Because of the difficulty involved with thoroughly identifying all of the hazards, ISO 14971 provides a number of aides – such as Annex C (2012) (becoming the ISO 24791 Annex A in the 2019 edition) – which provide a list of questions to assist in establishing device characteristics that may impact safety. Although not exhaustive, these questions can serve as a starting point and become one of several potential approaches from which the complete risk identification can be assembled. 

Aligned Elements users can kick start their risk identification process by downloading and importing our ISO 14971:2012 Annex C Extension, assessing them and start generating risks and mitigation. 

The ISO 14971:2012 Annex C Extension contains:

  • RVT file for an ISO 14971 Annex C Question and a corresponding DOCX Reporting style template
  • 37 importable questions built on Annex C in ISO 14971 to assess and integrate into your Risk Assessment

This Extension facilitates the assessment of the questions, the creation of both an automated assessment report of the Annex C questions as well as a starting point for generating new risks and mitigation. 

It gives medical device manufacturers a predefined starting point when setting up their technical file with the intention of accelerating the documentation effort.

The user is of course welcome to expand this question list with questions that are particular for his/her device and the conditions under which it needs to operate.  

The ISO 14971:2012 package can be combined with other risk identification packages from Aligned or in-house developed approaches by the manufacturer.

The ISO 14971:2012 Annex C package is free to Aligned Elements users.

For more information on how you can include our ISO 14971 questions in your risk assessment, contact the This email address is being protected from spambots. You need JavaScript enabled to view it. today. 

Aligned Elements V2.5 SP 3 released


Aligned Elements V2.5 Service Pack 3 (2.5.313/114.16963) is here with a great improvement and some important fixes.

What's New 

Collaborate using Comments

Use the Comments tab to add comments and send notifications to your team members. Comments can be used to discuss and clarify details or a particular design item during its life cycle. Emails notify comment authors about replies, upvotes, and mentions. Comments are only available in the Aligned Elements web client.

What's Changed

  • Important fixes regarding risk handling, Word, and merging

Upgrade now

With important improvements and a handful of fixes, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.5 SP 3 here.

Aligned Elements V2.5 SP 2 released

What's New


Aligned Elements V2.5 Service Pack 2 (2.5.307/109.16875) is here and includes several integration improvements and a number of fixes. 


Enterprise Architect Integration

Leverage the powerful System Integration models of Enterprise Architect in your Aligned Elements traceability! Enterprise Architect Diagrams can now be part of Aligned Elements item through a live connection with the Enterprise Architect repository enabling both traceability between Design Controls in Aligned Elements and models in Enterprise Architect diagrams as well as the incorporation of EA diagrams in Aligned Elements bi-directional Word reports.


Enterprise Architect


Integration with Redmine 

Use Aligned Elements integration with the popular Redmine ticket system to integrate Redmine tickets into your Design Control traceability. Create Redmine tickets from Aligned Elements on the fly when bugs are found during test execution, let Aligned Elements inconsistency checks validate the state of your Redmine items, and use Aligned Elements bi-directional Word Integration to incorporate Redmine ticket into your DHF documents. 




Web Client Improvements

We have made a number of usability improvements available in the Aligned Elements Web Client to make your work easier and faster. These include displaying chapter structure in Trace Dialogs, one-click 'Add to Review' action from several views, single-click 'Save document as PDF',  'Find In...' functions to locate Design Control Items in different contexts, Excel exports from tables, and much more.


Trace To


What's Changed

  • Integration with Perforce Jobs
  • Use Test Runs without Configurations
  • Single-click to find items in Trace / Project Explorer, Files and Test Runs
  • Compare Word documents using Word's Document Comparison feature
  • Save Files in their folder structure to disk
  • Convert files to PDF at save to disk
  • Do risk reduction in Hazard Analysis and not in Mitigations
  • Make Unlock Objects a separate user right
  • Save tables to Excel (Web client)
  • Revert to Revision (Web client)
  • Save Trace Table as word template (Web client)
  • Add to Review from several views (Web client)
  • Display items in chapter structure in Trace dialog (Web client)
  • Create Harms and Mitigations on the fly (Web client)
  • Optional mail invitations sent from Review and Signature (Web client)
  • Support for table operations in Table attribute (Web Client)

Upgrade now

With important improvements and a handful of fixes, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.5 SP 2 here.

Reducing the Design Documentation Effort with 80%


Sometimes I get the question "So how much time and money will I save by using Aligned Elements?"

A fair question and a question I can answer with a clean conscience: on average, you will save 30% or more of the time you currently spend on design documentation.

However, some medical device manufacturers can save (and have saved) a lot more than that!

If a modular documentation approach is applied, where reuse of already existing Design Control data is leveraged, there are examples of savings of up to 80%.

In this video below, you can find out more about the possibilities, prerequisites, and benefits received from Modular Design Documentation with Aligned Elements.

Happy Holidays!

Modular Design Doc Video


Aligned Elements V2.5 SP 1 released

What's New


Aligned Elements V2.5 SP 1 is a service pack consisting almost exclusively of bug fixes. 

What's Changed

  • Web Client optionally authenticates against Active Directory
  • Improved security mechanisms in Web Client
  • Improvements for Linked project handling in Web Client
  • Fixes in the Web Client Word Document Handling

Upgrade now

With important fixes, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.5 SP 1 here.

Software Change? Yes! - New 510(k)? Eh...


It is a well-known tendency that changes made to software (new features, bug fixes, etc.) often lead to new software errors. In a medical device context, this can have detrimental consequences.

The FDA requires that medical device manufacturers submit a new 510(k) when a marketed device has changes, including changes to software, that could significantly affect the safety or effectiveness of the device or when there are major changes in the intended use of the device.

Of course, the word "significantly" is the moving target here. To facilitate the decision whether a new 510(k) is required, the FDA issued the guidance document "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" in October 2017.

FDA Commissioner Scott Gottlieb said a statement that the guidance ..." enhances predictability and consistency for innovators deciding when to submit new 510(k)s by better describing the regulatory framework, policies, and practices underlying such a decision.”

Aligned has published an Aligned Elements Regulatory Wizard called When to Submit a 510(k) for a Software Change to an Existing Device that codifies this guidance document and makes it easy to assess and document whether the software changes (captured and managed in Design Control Items in Aligned Elements) will result in a new 510(k) or if documentation therefore suffices.


The wizard When to Submit a 510(k) for a Software Change to an Existing Device is freely available for download from the Extension section of this website and serves as yet another example of how Aligned Elements can reduce the development documentation effort of your device.


Aligned Elements V2.5 released

What's New


Aligned Elements V2.5 is here and brings a host of new enhancements and fixes. 


Branching and Merging Projects

Branch Aligned Elements projects to enable parallel development throughout the Product Development Life Cycle. For example, when V1.0 of your device has been released, branching the project ensures that your next release V2.0 can be developed in parallel with any fixes required to V1.0. Merge features back from a branch into the mainline with a few simple clicks.




Native Word Integration from Aligned Elements Web Client

The Aligned Elements Web Client now provides a native Word Add-In which makes it possible to an incredibly flexible report creator, freely mixing regular Word Content with Aligned Elements content. All Word Integration features available in the Aligned Elements Windows client are now available in our Web Application as well. Select a Document in Aligned Elements and Word will automatically start with the Word Add-In displayed on the right side of the Word application.




Risk Assessment Improvements

Upon customer request, we have expanded the range of options available for configuring Risk Assessments, including Probability and Severity text dropdowns, an unlimited number of risk zones with customizable coloring, and a fully customizable risk result presentation.




What's Changed

  • Automatically pre-populate project with content at project creation
  • Dynamic List Attribute - expand selectable items range from GUI
  • Group Test Runs
  • Group User Favourites
  • Filter Office Explorer on Tags
  • Workflow action: Generate Object
  • Enhanced Security
  • Incoming suspect Trace validation rule
  • Validation on Incoming Trace rule
  • Illegal Trace From validation rule

Upgrade now

With important fixes and a handful of improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.5 here.

The Aligned Elements Automation Tool


Reuse. Automation.
Two words we really like.
You should too since they mean less work for you!


In this spirit, we created the Aligned Elements Automation Tool to speed up your Medical Device documentation work.

Aligned Elements - configured to match the manufacturer's QMS

But first, let's take a step back.
As you might know, the way Medical Device Manufacturers compile their development documentation is largely defined in its Quality Management System (QMS).
The QMS defines the processes, SOPs and templates used to design and document compliant medical devices in the most efficient manner given the manufacturers' unique situation.

We go to great lengths to adapt and configure Aligned Elements to each customer's QMS.
The result is a unique configuration that helps the manufacturer to write consistent, complete, and compliant Design Control Documentation with minimal effort.
The configuration defines things like:

  • Consistent naming of all Design Controls
  • Customizable Quality Control checks
  • Flexible Risk Assessment parametrization
  • The Expected Traceability and rules to detect deviations
  • Customer-specific Report Designs

Each time a new Aligned Elements project is created, the configuration makes sure that the created content is structured and aligned with the manufacturer's QMS.

Reusing existing content

However, when documenting a device, it often turns out that much of the created content itself has the potential to be reused in other projects.
Moreover, if established content is used uniformly across all device projects, a higher degree of consistency is established.
Such content can include:

  • Standard Design Control Items
  • Chapter structures
  • Trace Tables definitions
  • Frequently used Queries
  • Dashboard setups
  • Chart settings
  • Project settings like E-signature preferences and Email SMTP settings
  • Users and User Groups

Automated Reuse

These things have always been reusable in Aligned Elements With the Aligned Elements Automation Tool, it is now possible to transfer these settings to new and existing projects with a single click.

Setting up a new Aligned Elements project containing your company's established best practices is done within seconds!
The Automation Tool is the best way to swiftly leverage existing content in a consistent manner and shorten the project setup time to an absolute minimum.

So how does it work?

The Automation Tool combines a number of action steps in a single xml file and executes these actions against a selected set of projects.

Automation Tool

Multiple actions against multiple projects are performed in a single session.

The Automation Tool is installed as a Windows Application for manual use, as well as a Console application that can be used and triggered from other programs. 

Note! The Aligned Elements Automation Tool leverages the Aligned Elements REST API. Deploying the Aligned Elements Web Application is thus a prerequisite to use the tool.

The Aligned Elements Automation Tool can be downloaded here.

Aligned Elements V2.4 SP 6 Released

What's New


This service pack contains an assortment of small to medium improvements. As always, it is based on a significant amount of input from the Aligned Elements User Community. The strongest focus is on improvements in user management, web usability, and Word reporting.


Improved User Handling

Collaboration with development partners in Aligned Elements is definitely something that will speed up your documentation work. But sometimes, some functions and data should stay off-limits for your partners.
With improved access management, Aligned Elements restricts access to functions and data and ensures that information is shared on a need-to-know basis. Optional log-in with Microsoft credentials is also possible, as well as optional display of full name and/or email of users wherever user actions are displayed.


User Groups


Inline Editing in Tables

The Aligned Elements Web client now supports inline editing in Design Control Items tables. This greatly improves usability as the Items don't have to be accessed individually for editing. A set of Items is opened for editing in table mode with a single click. Select the attributes to be displayed in the table, edit as you like, and save all items with a single click.




Word Improvements

Aligned Elements now optionally keeps track of Design Control Items inserted as Queries, Risk Tables, and Trace Tables and will highlight any outdated documents where the items have changed after they were placed in the document. More flexibility in handling Word Template variants and enhanced coloring of Risk Assessments are welcome contributions from our users.


version office 14


What's Changed

  • Automatically add new Items to active Tags
  • Test Runs - Automatic removal of old attachments and issues at re-execution
  • Test Runs - Assign failed tests to new Test Run
  • Project Search Bar in Open Project Dialog
  • Generate, copy or execute multiple items in a single action
  • Signature stamp improvements now include time and time zone information
  • Set Traces to existing items in Table Attributes
  • Import / Export of Project Settings
  • Synchronized import without synchmap files

Upgrade now

With important fixes and a handful of improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 SP 6 here.

Aligned Elements Hotfix V2.4 SP 5 Released

What's New


Aligned Elements V2.4 SP 5 ( is a hotfix for solving an upgrade problem for projects from V2.4 SP 2 and earlier to the newest version of Aligned Elements.

Upgrade now

This is the recommended version.

Find the installer to Aligned Elements V2.4 SP 5 here.

Aligned Elements V2.4 SP 4 Released

What's New


With a complete overhaul of the Aligned Elements Web Client frontend, we are pleased to give you a much better user experience. In this release, we also introduce the Aligned Element dashboards, improvements to the Review Experience as well as several changes requested by our customers (to whom we always listen!)



Have you ever thought that although there is an immense amount of valuable information in Aligned Elements, getting an overview of the current state of affairs is not particularly straightforward? Enter Dashboards, you can now configure your own cockpit from a large number of Widget types. Web client information at your fingertips!



Web Client Frontend UX Enhancements

With proper Sidebar navigation as well as side-by-side operations of Project/Trace Explorer and the Items, the need for jumping back and forth is significantly reduced. Event-based updates remove the need to manually refresh. A useful Test Run Burndown chart now tracks your progress.



Enhance Design Review UX

The Design Reviews now display the Design Control Items just like they appear in your documents. You can create and assign issues directly to the Design Control Items without having to leave the context. We have also added an option for the Reviewer to explicitly state completion of all assigned tasks with a single button click.



What's Changed

  • New Inconsistency rules for Missing Test Executions in Test Runs and Unique attribute values
  • Improvements in the management of External Issue Management systems
  • Clearing File attribute values
  • Warn on commit on selected inconsistencies
  • Improved performance for Cloud Projects

Upgrade now

With important fixes and a handful of improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 SP 4 here.

Download the EU IVDR General Safety and Performance Requirements


The IVDR (Regulation EU 2017/746), published in the EU Official Journal on May 5th, will have a significant impact on the manufacturers making IVDR products. 

IVDR EU Regulation 2017 746

The BSI Group calls the new risk classification in the IVDR  a “quantum leap” for products that could have been self-certified under the old directive to products soon needing notified body certification under the new regulation. Access to notified bodies has been identified as a major bottleneck in the years to come.

IVD companies targeting the European market should therefore move swiftly and resolutely if they desire to stay in business. Compiling the Technical File could be one such task.

The EU IVDR Annex I General Safety and Performance Requirements section corresponds to the Essential Requirements section in MDD Annex I.

If you want to check how your current Technical Files complies with these requirements, you can download our checklist here:

IVDR (EU 2017/746) Annex I General Safety and Performance Requirements

Just like the MDR Annex, I General Requirements, the IVDR Annex I counterparts are also available to Aligned Elements users as a free extension.

IVDR Annex I Requirements can be imported as Design Control into any of your Aligned Elements projects and included in the traceability. The extension corresponds to the requirements in the 31 page checklist and is made readily available in your traceability in a matter of seconds!

Kickstarting your Technical File compilation with the IVDR Annex I General Requirements extension, available to Aligned Elements users in order to help them accelerate their medical device Design Control documentation effort. Browse through the available extensions and discover how they could accelerate your project.

The extension is available here: IVDR (EU 2017/746) Annex I Extension

Aligned Elements V2.4 SP 3 Released

What's New


Continued integration with external systems has been the theme of this release. We are glad to have incorporated GitHub tickets into our ecosystem. Operating with Linked Projects has now also become easier.

Hello, GitHub!

We are finally integrating towards the tickets of the most popular source code control system on the planet! The GitHub integration allows you to create, modify and trace towards GitHub Tickets e.g. when you are performing your Tests.



Web Client Usability

Improved linked project support, as well as the display of Help Texts, have been implemented in this release.



Starting external processes

Via Workflows, it is now possible to start external processes, triggered by events in Aligned Elements. These external processes can be fed with Aligned Elements content for further processing.



What's Changed

  • A new Inconsistency rule detecting obsolete traces
  • Default texts in Table attributes
  • Renaming of Files in Web Client
  • Creating Projects with templates in Azure File Storage
  • Optional automatic updates of linked traces

Upgrade now

With important fixes and a handful of improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 SP 3 here.

Aligned Elements V2.4 SP 2 Released

What's New


In this release, we have continued to expand existing features in alignment with our customers' feedback. Charts are now persistent, the Web client is getting really smooth and the powerful Test Run gets even more powerful.


Although charts have been a feature of Aligned Elements for quite a while, you can now save them and integrate them into your Word reports. The Chart Designer lets you design and organize your charts and present the project's Design Control data in the most capturing way.


Web Client Usability

We have included popovers of Document Objects when hovering on Document Object IDs in the Web Client. This gives a quick preview of the item's content without having to leave your context.


Test Run Improvements

Test Runs have been enthusiastically received by the Aligned Elements User community. In this release, we have added newly requested features, improved performance, and fixed a number of bugs.


What's Changed

  • Two new Inconsistency rules
  • Signalize suspect traces across project boundaries
  • Improved import mapping capabilities
  • Improved reliability and performance for Word Reports
  • Additional DB security options- Chapter content optionally displayed as lists

Upgrade now

With more than 100 enhancements, fixes, and improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 SP 2 here.

Medical Device Cybersecurity Risk Management


Performing Medical Device Cybersecurity Risk Assessments is something we Medical Device Manufacturers must get used to. And the sooner the better, During 2016 and 2017 a mounting number of health associated cybersecurity incidents have been reported. Cybersecurity breaches may well become THE main safety concern in our industry within the next few years. Increased regulation on this matter is to be expected.


FDA has already published guidelines on its view on how medical device manufacturers ought to address cybersecurity in Medical Devices. The guidance outlines the documentation FDA expects to see in the premarket submissions as well as what is expected to be conducted for SOUPs and during postmarket activities.

At the core of this documentation lies the Cybersecurity Risk assessment. As already discussed, this type of risk assessment is slightly different to the typical Design Risk Assessment conducted during development.

To address this task, which many manufacturers will have to perform, we have developed a risk assessment template set specifically for documenting Cybersecurity risks and mitigations.

This template package is free to download and use for all Aligned Elements customers.

Are you interested in how the Cybersecurity Risk Assessment can be conducted and integrated with the rest of your Design Controls?

This email address is being protected from spambots. You need JavaScript enabled to view it. for a free demonstration!

The Aligned Elements Cybersecurity Risk Assessment package contains:

  • Risk assessment templates based on AAMI TIR 32, modeling Assets, Threats, Vulnerabilities and Risk Controls as Measures
  • More than 30 Best Practice Cybersecurity Risk Mitigations ready to use

If you are looking for a Cybersecurity Risk Assessment Word Template, you can download an example here:

Cyber Security Risk Assessment Word Template


Kickstart your Technical File with the EU MDR General Requirements


On May 5th, the final texts of the MDR (Regulation EU 2017/745) and the IVDR were published in the EU Official Journal

It's quite a chunk of text and if you have not yet started to update your Quality Management System, SOP:s, and Technical Files, you should (seriously!) take some to plan these actions accordingly.


The EU MDR Annex I General Safety and Performance Requirements section corresponds to the Essential Requirements section in MDD Annex I.

If you want to check how your current Technical Files complies with these requirements, you can download our checklist here:

MDR (EU 2017/745) Annex I General Safety and Performance Requirements Checklist

The MDR Annex I General Requirements are also available to Aligned Elements users as a free extension. This means that the MDR Annex I Requirements can be imported as Design Control into any of your Aligned Elements projects and included in the traceability. The extension corresponds to the requirements in the 37 page checklist and is made readily available in your traceability in a matter of seconds!

The MDR Annex I General Requirements extension is yet another of the many available free extensions available to Aligned Elements users which helps them accelerate their medical device Design Control documentation effort. Browse through the available extensions and discover how they could accelerate your project.

The extension is available here: MDR (EU 2017/745) Annex I Extension

Aligned Elements V2.4 SP 1 released

With the Aligned Elements V2.4 Service Pack 1 ( 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.

Aligned Elements V2.4 released


What's New

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!

Managing Test Runs

Plan and Manage Verification and Validation Tests in Test Runs.
Get a full overview of Test development and immediate feedback on Test Progression.

Test Management

Parallel Testing of Configurations

Assignment of Test Responsibilities

Test Run Progress Status Indicator


Organize with Tags

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 Improvements

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


Azure Cloud Server Deployment

The Aligned Element Server can now be deployed in the Microsoft Azure Cloud.
Minimize your IT burden by using our hosted solution.


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Aligned Elements configuration stored in secure cloud File storage

A faster way to get up and running



What's changed

  • Dynamic Word Reporting in the Aligned Elements Web Client
  • Word Report Performance and Reliability improvements
  • New Inconsistency rules and rule options
  • Enhanced DHF Index support
  • Trace table columns based on Queries
  • Use a larger range of attributes in integrated External Tickets
  • Locking of Design Control to prevent changes at certain stages
  • "Backlink" support in integrated External Tickets
  • SQL Server 2016 support


Upgrade Now

With more than 200 enhancements, fixes, and usability improvements, this release is a recommended upgrade.

Find the installer to Aligned Elements V2.4 here.

How to document a powered Exoskeleton according to the FDA


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:

  • 9 Potential Hazards (including mitigation strategies) outlined as exoskeleton associated risk factors by the FDA
  • 38 exoskeleton Special Control Requirements deduced from 21 CFR Part 890 Docket No. FDA-2014-N-1903

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


The Aligned Elements IEC 62366 Usability Configuration


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:

  • 8 Design Control templates for capturing the input and output elements of the usability process
  • Pre-configured content validation checks assessing the consistency of the project in real-time
  • ISO 14971 compliant risk management to identify, assess and mitigate Use Error-driven risks
  • Interactive Checklist for reviewing the Use Specifications Document against IEC 62366-1:2015 
  • 20 usability example risks for Use Errors during the Transport, Storage, Installation, and Decommissioning
  • 2 preconfigured Traceability Tables
  • Integrated test protocols for established test methods such as:
  • Cognitive Walkthrough
  • Heuristic Evaluation (based on the Nielsen-Schneidermann heuristics)
  • Simulated-Use Testing for Usability Validation

On top of all that, the Aligned Elements IEC 62366 includes all the standard features of Aligned Elements, including:

  • Completed change control of all Design Control Items
  • Complete audit trail for all changes
  • Keep your company specific look and feel of all report outputs
  • End-to-end traceability with real-time impact analysis
  • Easy and fast Word reporting using drag and drop
  • FDA QSR 21 CFR Part 11 compliant User Management
  • Efficient decision-making process using workflows and E-signatures

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 This email address is being protected from spambots. You need JavaScript enabled to view it. to set up an appointment.

Digitization of the Med Tech Industry


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.

E Health 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:

  • Electronically sign and release document
  • Automatically route documents according to a workflow process
  • Push released documents to external systems
  • Collaborate on the documentation creation, management, and review
  • Perform real-time consistency checks at any time
  • Synchronize documents and generate traceability tables with a single click

Read more about Aligned Elements here.

Aligned Elements V2.3 Service Pack 5

What's New

Performance Improvements

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.



Usability Improvements

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.



Improved Signing Experience

List your pending signature tasks with a single click. Electronically sign single or multiple documents with a simple point and click. 




What's changed

  • Web client Clear Suspect Traces support added
  • Web client Synchronization of Word files support added
  • Expanded Double attribute options
  • Expanded Copy To File workflow options


Upgrade Now

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.

Hotfix Aligned Elements V2.3 SP 4 released

With the Hotfix Aligned Elements V2.3 Service Pack 4 ( 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.

Aligned Elements V2.3 Service Pack 3


What's New

Cloud Deployment

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. 




Fast and Flexible Word Reports

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!



Simple signing with electronic signatures

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.




What's changed

  • Web client Display Snapshot support added
  • Web client Word document creation and synchronization added
  • Web client Electronic signatures added
  • Web client Batch editing support added
  • Web client Export functionality added
  • New Project information placeholder 
  • Absolute mitigation reduction calculation
  • Support for Word 2016
  • Support for Windows 10


Upgrade Now

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.

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