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An upgraded User Experience - New Features Coming Soon!

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You wanted it, we're bringing it.

By popular request, we're introducing a bundle of UI improvements to our Aligned Elements Users.

An Upgraded Review Experience

Our popular Design Review functionality permits online collaboration during the review process. Each user enters observations and feedback at their own pace, which later can be addressed in an organized fashion.

However, the Review process may differ from company to company and hence, the Aligned Elements community reached out to us with suggestions to strengthen the Design Review further.

In Aligned Elements V3.0, we have therefore added things, like:

  • Marking review Feedback Comments as "Resolved" or "Declined"
  • Alternative Review outcomes, such as "Rejected" and "Postponed"
  • Visually indicating whether an item has been changed during the Review 
  • A detailed Word Gap Report showing all review changes for each item, with side-by-side colour-coded comparison
  • Displaying current Issue status in the Review Feedback and Overview Views
  • Auto-suggestion of Snapshot name for Review Snapshots

NewReview

We are grateful for the input the Aligned Elements community has provided us with, that has given us an opportunity to provide a richer Review experience.  Keep those suggestions coming!

Test Run Management Performance enhancements 

Testers tend to be the user group most intensely working with Aligned Elements. Therefore, giving them the best possible user experience is the least we can do to help. As a result, we have improved the Test Run and Test Run Explorer loading time, to speed up the switching between Test Runs, and Test Runs and Test artefacts.

Test Run Explorer

We have also worked on speeding up the Trace setting mechanism, as well as cutting the execution times for queries and Word Report generation for artefacts with incoming traces.   

New User Interface functions

We are excited to present a large number of new functions available in the Web Client User Interface. We hope that these will make the experience of Aligned Elements even more enjoyable.

Examples of these new features include:

  • Copy-paste of images from Word to Aligned Elements 
  • Resize-ability of the Chapter View
  • Copy Chapter structures from one Design Control type to another 
  • Edit File attributes in Display-As-List mode 
  • Optionally refresh the Inconsistency Lists after resolving inconsistencies 
  • Copying Design Control Items between Projects
  • Support for disabling Snapshots
  • Optionally rejecting in a Signature situation

These changes are available in the upcoming Aligned Elements v3.0 release.

Creating Documents just got faster! - New Feature Coming Soon!

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One of our best known features is Aligned Elements Word Integration.

This unrivalled feature lets you compose Design Control documents by filling your Word Templates with content from Aligned Elements.

You decide which data goes where and what the data should look like. The output is tailored to your company's process, product, templates and corporate design.

This is pure flexibility and adaptability, where you are in total control of the document creation.

When Control and Speed is all you need

However, there are situations where you don't want all that flexibility, cases when you need quite the opposite.
Let's take the case of a Risk Assessment document.
Your Risk Assessment word template has been meticulously crafted by your quality department.
The template is set up to keep:

  • the Risk Identification list in section 3.2
  • the Risk Assessment itself in section 5
  • a Graphical Risk Summary in section 6 and
  • a list of residual risks in section 7.3.

All this data is available in Aligned Elements and your task is now to move it to the document itself. 

The task is structured and clear. In this situation, flexibility and creativity is not necessarily what adds value. 

Here our new feature come in to play.

Introducing the Document Creation and Population Assistant

With Aligned Elements V3.0 introduction of the Document Creation and Population Assistant, you can now set up your Word Templates for automated creation and population. 

In a few single clicks, the document is created and populated with Aligned Elements Design Control data without even having to open Word!

Select your word template in the Assistant and Aligned Elements will display the detected insert points. You can select among the data available in your project, or let Aligned Elements automatically suggest the data for your.

Autopopulate Document

One click later, the document is created and populated automatically, becoming readily available in your Technical File.

The upsides for you are:

  • Less time spent on creating documents
  • Consistent Design Control placement in the documents
  • Less risk for human errors

Freeing up time for innovation

It has always been our goal to cut the time spent on medical device documentation.
In our effort to free up even more time, we think we have come up with a helpful way to get to your documentation even faster.

This new feature is particularly interesting for medical device manufacturers that a rapidly expand their product portfolio or for projects with many re-occurring document types such as Test Case Reports, Review Protocols or Change Request documents.  In other words, when many similar documents are frequently created, the Document Creation and Population Assistant is an excellent way to save time.

The Document Creation and Population Assistant is available in the Web Client of our upcoming Aligned Elements v3.0.

Released Documents View - New Feature Coming Soon!

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Let's be frank.

Documentation plays a crucial role in your QMS.

The efficiency of your medical device company relies on your ability to manage and control the technical documentation.

These documents, being required by ISO 13485 and FDA QSR 820, must be correct, complete, and consistent.

To achieve this, solid document control is required.

However, systems and procedures that do not support efficient and streamlined document control can make the work overwhelming. When scrambling to get the Technical File ready for release, a stream of documentation activities occurs in parallel, with multiple updates and releases taking place frequently and simultaneously.

Released documents - up front

Attaining an overview of the currently approved, released state of all documents can be challenging and failing to do so, resulting in sending, or operating on, an outdated document version, can have significant effects.

For this reason, we announce the new "Released Documents" view, providing an unambiguous overview of the currently released documents in a single place. The documents displayed are your published, approved, and effective documents, in-short, your single source of (document-) truth.

Your team gets swift and exact access to the currently approved documents, appreciated during hectic audits and when scrambling to finalizing a submission. From now on, released documents are easily distinguishable from drafts, obsolete or superseded versions.

Released Document

Powerful and flexible document management 

The released state of your documents can be established with or without Aligned Elements built-in 21 CFR Part 11 compatible electronic signatures. Thus, you can decide yourself what makes a document being "released" in your Aligned Elements setup. 

The released documents are organized and displayed in their corresponding file chapters for easier orientation. Additionally, visual indicators highlight documents where a new version is currently being drafted.

Filtering, searching, and sorting can be done using Aligned Elements standard mechanisms. In addition, Aligned Elements Tags can be applied to achieve quick filtering and grouping for selected purposes, such as all documents applicable to a standard or a geographical market.

Bulk operations such as download, analysis and report generation are available per default. Read-access to the "Released Documents" view is available to all users per default but can be displayed selectively by assigning the appropriate user permissions.

Edit Documents View - the broader and deeper access

The Released Documents view is the go-to place when looking for the currently approved and released version of a document.

However, for getting a broader and deeper view of the current work state, the "Edit Documents" view provides the tools you need. This view displays all documents in their live state, including unreleased documents in draft and ongoing updates of already released documents.

Conclusion

To provide a straight-forward and yet flexible Document overview that matches your organizations needs, this feature strengthens, streamline, and promote good document control practice in your Aligned Elements projects.

By integrating this new feature, you will achieve:

  1. Direct and unambiguous entryway to released documents
  2. Protection of documents from unauthorized access
  3. Better and faster support for compliance activities
  4. Improved document security

The Released Document view is available in the Web Client of our upcoming Aligned Elements v3.0.

Hotfix Aligned Elements V2.6 Service Pack 2 released

With the Hotfix Aligned Elements V2.6 Service Pack 2 (2.6.425/180.21104) we have fixed an important bug detected in V2.6 SP 1.

This bug fix concerns the trace direction of traces between Causes and Risk Analysis/Hazards Analysis objects in the Web Client, which were, at times, incorrectly set in V2.6 SP 1. 

Release notes can be found here.

This release is a recommended upgrade.
Find the installer to Aligned Elements V2.6 SP 2 here.

Webinar: New in Aligned Elements V2.6 Service Pack 1

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In this latest release of Aligned Elements V2.6 Service Pack 1, we tell you all about...

  • Search-as-you-type in the Word Add-In
  • Import Files in batch
  • User and Project Management improvements
  • Integration with Open AI

 

The webinar can be viewed below:

Enjoy!

Aligned Elements V2.6 Service Pack 1 released

What's New

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Aligned Elements V2.6 SP 1 (2.6.176/419.20790) is here and includes a number of bug fixes and a couple of new features.

Upload Multiple Files

Perform bulk upload of files with a single click to Design Control types like Files and Attachments. Aligned Elements automatically creates the item, attaches the file, sets the title and recreates the chapter structure from the uploaded folder structure.   

 Import Files

 Search-as-you-type in Word Add-In

Locate your target Design Control Items quickly with search-as-you-type in the Aligned Elements Word Add-In.

  Serach as you type

Import Design Controls to selected Target Chapter 

More control over your import actions are facilitated with the new option of importing Design Control Items into a selected chapter.

Import in Chapter

What's Changed

  • Aligned Elements Automator runs on both Linux and Windows
  • Customize wording for risk labels (Acceptable, ALARP, Inacceptable)
  • Improvements in Font and Formatting control
  • More control over Exported Excel Reports
  • Automatic email send out for signatures with enforced signing order
  • Prevent selected attributes to be copied at Generate
  • Display total number of Active Users
  • SQL Server 2022 compatibility

Upgrade now

With new features and important fixes, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.6 SP 1 here.

Webinar: New in Aligned Elements V2.6

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In this latest release of Aligned Elements V2.6, you find great new features such as...

  • Trace Tables based on Snapshots
  • Chapter Descriptions
  • Traced Object Attributes
  • Automatic Recovery of Data

 

The webinar can be viewed below:

Enjoy!

Aligned Elements V2.6 released

What's New

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Aligned Elements V2.6 (2.6.157/401.20382) is here and includes new capabilities and numerous bug fixes.

Chapter Descriptions

Use Chapter Descriptions in Aligned Elements to add text displayed right below the Chapter when inserted in a Word Document. 

Chapters

 

Create rich Design Controls using Traced Object Attributes

The traced object attribute permits you to display data from traced objects in your Design Control. This can be singles Design Controls or lists of Design Controls, appear being embedded as attributes in your main Design Control.

Traces 

  

Inspect indirectly traced Design Controls 

Hover with the mouse on trace inthe 'Trace To' and 'Trace From'-tabs to see indirect outgoing or incoming traces.

Traces

What's Changed

  • Trace Tables from Snapshot
  • Automatic Recovery of Unsaved Data
  • User Right for Test Run Management
  • Promote Comments to Issues in Review Feedback Overview
  • Trace Table allows "Upward" and "Advanced" at the same time
  • Export and import of Tags
  • File Object Revision History indicates Signed Documents
  • GemBoxPDF as new standard PDF Converter
  • Security Updates

Upgrade now

With new features and important fixes, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.6 here.

New Extension - Internal Audit Checklist for ISO 13485:2016

There are few standards that have higher influence on the daily workday than ISO 13485. Most processes used by a Medical Device manufacturer are mentioned and regulated by this ISO standard.

If you want to check how well your organisation fulfils the ISO 13485, you can use this new Aligned Elements Extension in your Aligned Elements instance.

iso logo

This checklist extension covers key clauses in the sections:

4 - Quality management system
5 - Management responsibility
6 - Resource management
7 - Product realization
8 - Measurement, analysis, and improvement

With this checklist it is easier for you to assess what you have completed and what the remaining items are. Use the standard Aligned Elements functions to collaborate, analyse and report your results. 

How does the ISO 13485 Checklist work?

The ISO 13485 Checklist Extension consists of:

  • A new template called "Checklist Item" incl. a Word Template for this type
  • 143 importable checklist items that cover chapter 4 to 8 in ISO 13485:2016
  • Each item contains a control question, an assessment of the question and a placeholder for adding evidence for the assessment

Use this checklist to get a properly controlled and document proof of your fulfilment of ISO 13485.

Note! This Internal Audit Checklist for ISO 13485 only works in Aligned Elements.

The Aligned Elements OWASP Top 10 Checklist available now

As a medical device manufacturer, you are probably well aware of the increasing focus on cyber security. When developing your device, you are responsible for ensuring that it is safe to use from a cyber security perspective.
I think it is safe to say that the attention placed on cyber security aspects by autors and national authorities will only increase in the coming years.

FDA has issues a number of guidelines on how to implement and apply cybersecurity both on a process and product level. It is up to you as a medical device manufacturer to provide adequate cyber resilience in your products as well as the documentation required to prove it.

Aligned Elements users have for a long time been able to leverage Cyber Security extensions in their Aligned Elements configurations such as the Medical Device Cybersecurity Risk Assessment Templates and the Johner Institute Medical Device IT Security Product Requirements.

We are now happy to include the new OWASP Top 10 Checklist to our library of Cyber Security Extensions.

TOP 10 logo Final Logo Colour

What is it?

OWASP stands for “Open Web Application Security Project”. It is a non-profit entity with international recognition and focuses on collaboration to strengthen software security around the globe.

OWASP publishes the OWASP Top 10 list, which provides rankings of, as well as a remediation guidance for, the top 10 most critical web application security risks.

It uses the extensive knowledge and experience of the OWASP’s open community contributors, and is based on a consensus among security experts from around the world.
The OWASP Top 10 risks are ranked according to the frequency of discovered security defects, the severity of the uncovered vulnerabilities, and the magnitude of their potential impacts.

You can now easily assess and automatically document how well your medical device application stands up against the OWASP Top 10 by applying the Aligned Elements OWASP Top 10 Regulatory Assistant in your Aligned Elements projects.

How does it work?

This Assistant takes the shape of a Checklist where you assess your own medical device against the OWASP Top 10 security risks.

You start out by assessing whether the risk is applicable to your device at all, and if not, provide a qulified answer why this is not the case (the auditors rewards such qualifications).

If the risk is applicable, you are required to refer to the Aligned Elements Design Control Items that addresses the risk by selecting them in the UI.
You can compare your risk reduction controls against known best-practice remidiations mentioned in the OWASP Top 10 list.

When the checklist is completed, a Regulatory Assistance item is generated, containing all steps and your provided answers. This information remains stored in Aligned Elements for compliance purposes.

The OWASP Top 10 Regulatory Assistant Checklist is free to all Aligned Elements customers and can be applied to any Aligned Elements Web Server installation.

Note! The OWASP Top 10 Regulatory Assistant Checklist only works in Aligned Elements.

Webinar: New in Aligned Elements V2.5 SP 6-7

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In this latest release of Aligned Elements, you can find...

  • Drag and Drop Support
  • Resolve inconsistencies by click
  • Positive Cues
  • Regulatory Assistants

 

The webinar can be viewed below:

Enjoy!

Aligned Elements V2.5 SP 7 Hotfix released

What's New

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Aligned Elements V2.5 Service Pack 7 (2.5.148/377.19484) is a hot fix for V2.5 SP 6 to fix a few important errors detected in that version.

Upgrade now

This release is a recommended upgrade.
Find the installer to Aligned Elements V2.5 SP 7 here.

Aligned Elements V2.5 SP 6 released

What's New

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Aligned Elements V2.5 Service Pack 6 (2.5.144/373.19437) is here and includes new capabilities and numerous bug fixes

Drag and Drop Operations in Web Client

Setting incoming and outgoing traces and adding attachments is now possible using drag and drop, a faster and more intuitive way to work. 

Drag_And_Drop.PNG

 

Fixing Inconsistencies on the spot 

Unveiling inconsistencies and quality errors has always been one of the great advantages with Aligned Elements. Now, inconsistencies can be solved on the spot with just a few simple clicks. Aligned Elements offers a well curated selection of solutions to choose from, all adapted to your configuration, your access rights and the current project context. 

Resolve.PNG 

  

Positive Cues - Indication of the Design Control's "health"

A Document Objects "health" is clearly displayed as a coloured dot in several list views. A Positive Cue is a collection of inconsistency rules that are evaluated together. The Positive Cue bar displays all Positive Cues available for the Design Control and also gives direct access to resolution options.

Positive Cues

 

Regulatory Assistants 

Run a Regulatory Assistant to quickly create or import Design Control items from predefined repositories and/or dynamically created items based on your user input.

Assistant 

What's Changed

  • Paste Images directly into Richtext and Table Attributes
  • Possibility to Map unknown import data to known project data
  • Assign User Groups as signees
  • Enforce order of Signing
  • User Management Enhancement
  • Allow adding new entries to Dynamic List Attributes on the fly
  • Two Factor Authentication in Web Client
  • Test Run: Batch Assign Users and Configurations to Test Cases

Upgrade now

With new features and important fixes, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.5 SP 6 here.

Design Controls according to IEC 82304

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When you think about standards for medical device software, IEC 62304 is probably the first one that comes to mind. If you develop software for medical devices, this is definitely the standard you should look into.

Less known is IEC 62304's bigger brother, the IEC 82304 "Health software — Part 1: General requirements for product safety" which expands on the IEC 62304.

So what are the main differences?  When shall I use which standard?

Differences between IEC 62304 and IEC 82304

Scope

IEC 82304 targets a larger range of device types than IEC 62304. IEC 82304-1 targets any kind of software, which directly or indirectly has an effect on health, known as "health software" in the standard.
In contrast, IEC 62304 only targets software with medical intended use.
Examples of device types that are in the scope IEC 82304 but not IEC 62304:

  • Radiology Information Systems
  • Prescription Management Systems
  • Laboratory Information Management Systems
  • Mobile Apps (not defined as FDA Mobile Medical Apps)

Standalone

IEC 82304 is intended for standalone software and not as IEC 62304, software embedded in medical devices or embedded in devices with specific hardware.
Software running on PCs, Server or Mobile Devices on a general purpose Operating System are in the scope of IEC 82304.

Product Life Cycle Stages and Design Control Levels

As mentioned, IEC 82304 expands on IEC 62304 and addresses both additional Design Controls and requirements on expanded parts of the Product Life Cycle.
It includes Product Use Requirements as well as Product Validation Plans and Reports. It specifies requirements on Product Identification and Instructions For Use as well as Post-market activities.

IEC 82304 references IEC 62304 for software development and maintenance, i.e. on a software level.

Aligned Elements IEC 82304 Configuration

The Aligned Elements IEC 82304 configuration is a superset of the IEC 62304 configuration. It expands the IEC 62304 configuration with Product Use Requirements and Product Validation Tests. It 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 82304 configuration contains:

  • Pre-configured templates using IEC 82304 standard naming conventions
  • Software Safety Classification automatically based on risk analysis results
  • Numerous quality checks for consistency verification
  • Pre-configured Reviews and checkpoints according to IEC 82304 and IEC 62304 stipulations
  • Pre-configured Trace Tables based on the IEC 82304 and IEC 62304 requirements
  • A set of document templates being a great starting point for your documentation
  • 48 importable Product Use Requirements for Accompanying Documentation from IEC 82304

The Aligned Elements IEC 82304 supports documentation management of:

  • Product Use Requirements
  • Product Validation Tests and Results
  • System and Software Requirements
  • Software Architecture building blocks(Software Items, Units, SOUPs, and segregations)
  • Risk Management using a Preliminary Hazard Analysis technique (listed in ISO 14971)
  • Software Verification  (Unit, Integration and System testing)
  • Change and configuration management (Problem Reports and Change Management)

The Aligned Elements IEC 82304 Configuration can be downloaded here.

Webinar: New in Aligned Elements V2.5 SP 5

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In this latest release of Aligned Elements, you can find...

  • A new Review Feedback Overview
  • Project Maintenance Actions for Web Admins
  • Several improvements on popular request

 

The webinar can be viewed below:

Enjoy!

Aligned Elements V2.5 SP 5 released

What's New

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Aligned Elements V2.5 Service Pack 5 (2.5.357/130.18463) is here and includes some awesome new features and a host of bugfixes

 

Web Client Admin Operations

Web Admins now have direct access to database management, template management and enhanced user management.

 

Web Admin

 

Design Review Feedback Overview 

A new feedback overview displays the aggregated feedback from all users participating in the review.

 Reveiw Feedback

  

What's Changed

  • Insert Project Information attributes into Word as fields
  • Separate scrolling of Base form and Chapter list (Web Client)
  • Add to Test Run from Form (Web Client)
  • Add to Tag from Form (Web Client)
  • Enhancements in Issue proxy Authentication process 
  • Optional prohibition of Severity reduction FMEA:s 
  • Revision list always displayed with the latest revision on top (Web Client)
  • Allow use of text color and text background color in Rich Text and Table Attributes (Web client)

Upgrade now

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

Software Hazard Identification based on IEC 80002-1 Annex B

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ISO 14971 provides great assistance when identifying potential Hazards through its annexes, but it does lack a strong identification catalogue for Software Hazards. 

Luckily, IEC TR 80002-1:2009 Annex B comes to rescue. This Technical Report, "Medical device software - Part 1 Guidance on the application of ISO 14971 to medical device software", takes a software angle on ISO 14971, just as the title suggests.

Annex B of the report elaborates on possible software hazards and factors to consider in order to properly assess whether and how they are applicable to a particular device. 

To assist the risk identification of software hazards, we have built this extension, inspired by the Annex B of IEC/TR 80002-1. 

It includes:

  • RVT file for a Software Hazard aspect and a corresponding DOCX Reporting style template
  • 70+ importable potential Software Hazards to assess and integrate into your Risk Assessment

You may of course expand this hazard list with hazards that are particular to your device and the conditions under which it needs to operate.  

This extension package can be combined with other risk identification packages from Aligned or in-house developed approaches by the manufacturer.

The "Software Hazard Identification based on IEC 80002-1 Annex B"  extension is free to Aligned Elements users.

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

IEC 62304 Checklist for Software Audits

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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

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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. 

Enjoy!

 

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

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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

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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 (http://www.imdrf.org) 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 (https://ec.europa.eu/docsroom/documents/41681).

These codes can also be used when reporting Adverse Events to the FDA by means of a Medical Device Report (https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/mdr-adverse-event-codes).

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

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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

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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. 

 

redmine

 

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%

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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

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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...

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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.

SoftwareChanges

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

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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.

 

Branch

 

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.

 

WordAddIn

 

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.

 

risks

 

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.