Aligned Elements is a Medical Device application lifecycle management (ALM) solution enabling fast development and regulatory compliance through improved Design History File management.

August 14 2019

It is a well known tendency that changes made to software (new features, bug fixes etc.) often leads 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 devices 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 guidence 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 ..."enhance predictability and consistency for innovators deciding when to submit new 510(k)s by better describing the regulatory framework, polices 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 asses 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 thereore 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.

 

June 27 2019

What's New

Aligned Elements V2.5 is here and brings a host of new enhancement 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, unlimited number of risk zones with customizable coloring and 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 improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.5 here.

April 07 2019

 

Sharpen your Skills 2019

May 21st, 2019 | HWZ University, 3 minutes from Zürich Main Station


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Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2019.

We have called on a group of experienced industry expert to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

We look forward to see you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.

REGISTER NOW!


Key Learning Objectives

The way to MDR: real world experience

The MDR transition window is closing. Manufacturers, Notified Bodies, and Distributors are working vehemently to reach the opposite shore in one piece.
An excerpt of the experience of adapting to these new requirements, including hints and best practice are presented in this session.

Presented by: Hansjörg Riedwyl, CEO, ISS AG

Hidden cost drivers in clinical investigations - the importance of strategy

Market access and approval is more dependent than ever on clinical data. Getting your clinical trial design right, in time and within budget, is one of the most important steps.
This session focuses on the importance of collaboration with regulatory and clinical operations experts to minimize the risk for delays as well as the costs.

Presented by: Carin Nilsson, Partner, Confinis CPM

Computer System Validation CSV – between ZERO and HERO

How to best handle the conflicting expectations from Management, IT, Quality Department and (last but not least) the Auditor?
Gerhard Dariz provides deep, real-world insights from corporate practice and show possible strategies to survive this area of tension.

Presented by: Gerhard Dariz, CEO, Inmedis GmbH

Clinical Evaluation and Post Market Clinical Follow-Up under MDR

MDR introduces important changes in expectations on how to demonstrate device safety and performance prior to market access.
This session provides an overview and hands-on examples of the Clinical Evaluation and Post-Market Clinical Follow-Up processes under the MDR.

Presented by: Dr. Autumn Lang, CEO, Confinis CPM

Automated Design Control Documentation

Machine Learning. Digitalization. The future holds a promise of machines performing more and more of our daily tasks. However, many of us are still putting Design Control Documentation together character by character. Can the Design Control Documentation be automated? What would that look like? What are the limitations?

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG


Time and Place

  • Date: Tuesday May 21st
  • Time: 08:15 - 13:30
  • Place: HWZ University, Zürich

Presentations are held in German. Slides written in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel and other industry professionals engaged in medical device development.

Registration

We are looking forward to see you at this seminar!

Registration Fee: 125 CHF

30% early bird discount for registration before May 1st.

REGISTER NOW!


Location

Address: HWZ Hochschule für Wirtschaft Zürich, Lagerstrasse 5, Zürich

HWSMap

 

About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.

 HTCS

March 22 2019

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

Robot

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 a Medical Device Manufacturer's 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 customers 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 manufacturers QMS.

Reusing existing content

However, when documenting a device, it often turns out that much of the created content itself has 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 which can be used and triggered from other programs. 

Note! The Aligned Elements Automation Tool levereges 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.

February 08 2019

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 the 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.

 

InlineEditing

 

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 includes 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 improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 SP 6 here.

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