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System Requirements

System Requirements

Web Client

Recommended Requirements

Browser

Currently stable release of Edge, Edge Chromium, Google Chrome, Firefox or Safari

MS Word

Standalone Word 2019 or later (32-bit or 64-bit) or

Word 2013 or later with Office 365

Windows Server Requirements

Recommended Requirements

Processor

2 cores

RAM

8 GB

Hard Drive

250 GB

Operating System

Windows Server 2012 or higher

Database Server

Aligned Elements uses Microsoft SQL Server for persistence.

SQL Editions

SQL Server Enterprise, SQL Server Standard, SQL Server Web and SQL Server Express with Advanced Services are supported.

SQL Versions

SQL Server versions 2005, 2008, 2012, 2014, 2016, 2017, 2019 and 2022 are supported.

Web Application Server Requirements

Recommended Requirements

Web Server

Aligned Elements uses Microsoft IIS Web Server.

Version

IIS 8 or higher


Windows Client

Recommended Requirements

RAM

4 GB

Hard Drive

2 GB Free Space

Operating System

Windows 7, Windows 8, Windows 10, Windows 11

MS Word

Word 2013 or later (32-bit or 64-bit)

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  • Let's find out which pricing plan fits your needs best


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Try free Trial

Get Started With a Free Trial Today!

Try our world-class eQMS and Design Control Management and see how hundreds of Medical Device companies accelerate their journey with Aligned.

What you get for free:

  • 30 days free trial
  • Access to the Aligned eQMS
  • Access to the Aligned Elements ALM
  • Medical Device example projects included
  • Free technical support

No Credit Card needed!

If you need a trial extension, just let us know.

Don't miss out our follow-up support while you try aligned elements and receive tips on a regular basis

Need to know more?

If you want assistance to try your own QMS and/or development process in Aligned Elements, we'd be happy to assist you and work out a trial configuration for you.

Seeing your existing development documentation data in Aligned Elements can make it easier for you to assess how the system could assist your organization. We can help you parse and import your existing documentation into a test project.

How do the Aligned Elements Licensing plans work?

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Feel free to contact us if you have any questions.

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Pricing

Pricing Plans

Start a free 30-days trial today!

Find out more about our package offerings below!

Aligned Elements

Design Control ALM

650€

per month
Incl. 2 Floating Licenses
billed yearly

Request a Quote

  • Full Design Control Mgmt
  • ISO 14971 Risk Management
  • End-to-End Traceability
  • Auto-Consistency Checks

Aligned eQMS

Popular

Starter Package

1000€

per month
Incl. 3 Floating Licenses
billed yearly

Request a Quote

  • All Aligned Elements Features
  • 14 SOP:s and 55 Templates
  • Document & E-Signature Support
  • Training Management
  • Supplier Managemenet

Aligned eQMS

Full Package

2085€

per month
Incl. 5 Floating Licenses
billed yearly

Request a Quote

  • All Aligned Elements Features
  • 31 SOP:s and 100+ Templates
  • Quality Event Management
  • Audit Management
  • Equipment Managemenet

Aligned Elements

Design Control ALM

400€

per month
Incl. 2 Floating Licenses
billed yearly

Request a Quote

  • Full Design Control Mgmt
  • ISO 14971 Risk Management
  • End-to-End Traceability
  • Auto-Consistency Checks

Aligned eQMS

Popular

Starter Package

850€

per month
Incl. 3 Floating Licenses
billed yearly

Request a Quote

  • All Aligned Elements Features
  • 14 SOP:s and 55 Templates
  • Document & E-Signature Support
  • Training Management
  • Supplier Managemenet

Aligned eQMS

Full Package

1830€

per month
Incl. 5 Floating Licenses
billed yearly

Request a Quote

  • All Aligned Elements Features
  • 31 SOP:s and 100+ Templates
  • Quality Event Management
  • Audit Management
  • Equipment Managemenet

Compare Plans

  Aligned Elements eQMS Starter eQMS Full
  • Design Control Management
    Flexible Requirement Management
    ISO 14971 Risk Management
    AI-Driven Verification Management
    Design Validation Management
    End-to-End Traceability
    Automated Consistency Checks
    Integrated Design Reviews
    Use Scenario & Task Management
    Powerfull Tech Doc Reporting
    Integrated DHF Index
    E-Signatures 2000 EUR
  • QMS Content
    Included SOP:s - SOP101 Human Resources
    SOP200 Design and Development
    SOP204 Software Development
    SOP208 Cybersecurity Management
    SOP209 Released Software Management
    SOP300 Documents and Records
    SOP301 Performance Evaluation
    SOP302 Change Management
    SOP303 Infrastructure
    SOP304 Supplier Handling
    SOP305 Risk Management
    SOP306 Usability Engineering
    SOP307 Labeling
    SOP308 Validation of Computer Software
    _____
    10 000 EUR
    All SOP:s in Starter Pack
    SOP100 Management
    SOP102 Audits
    SOP103 PMS
    SOP104 Complaints and Vigilance
    SOP105 Corrective and Preventive Action
    SOP106 Nonconforming Product
    SOP201 Purchasing
    SOP202 Production
    SOP203 Sales
    SOP205 Incoming Inspection
    SOP206 Storage Packaging Delivery
    SOP207 Technical Service
    SOP301 Clinical Evaluation
    SOP309 Statistically Valid Sampling
    SOP310 Process Validation
    SOP311 Equipment Control
    SOP312 Device Cleanliness Sterilization Contamination Control
    _____
    20 000 EUR
  • Training Management
    Automated Action Assignment -
    Training/Document Linking -
    Training Progress Tracking -
  • Change Management
    Change Request Management -
    Change Request Planning -
    Change Request Reporting -
  • Supplier Management
    Supplier Selection & Approval -
    Supplier Handling -
    Supplier Re-Evaluations -
  • Computer System Validation Management
    Software Tool Library -
    Risk-Based Validation Assessment -
    GMP & FDA 21 CFR Part 11 Assessment -
    Validation Planning -
    Validation Reporting -
    Periodic Re-evaluation -
  • Quality Event Management
    Feedback & Complaints Management - -
    Nonconforming Products - -
    Nonconformity Assessments - -
    CAPA Management - -
    Vigilance Reporting Management - -
  • Audit Management
    Audit Program Management - -
    Audit Planning - -
    Audit Reporting - -

Additional Packages

Getting up and running fast is important for most of our customers. To provide best possible fit between Aligned Elements and your existing organization, we offer the following add-ons:

Configuration Support 3500 €

Aligning with your Development Process

We configure Aligned Elements according to your quality management system for seamless integration with your existing Development processes and templates.

On-Site User Training 2500 €

On-site User Training

Full-day training of up to 12 of your employees on your company site. The training warrents a certificate of completion if the final test is passed.

Online User Training 1200 €

Online User Training

Four two-hour online sessions for 12 users. The training warrants a certificate of completion if the final test is passed.

Integration with External System 2000 €

Integration with External System

Integrate Aligned Elements with Jira, TFS, Enterprise Architect, GitHub and many other system to get the most out of your existing infrastructure.

Integration with Automated SW Tests 2000 €

Integration with Automated SW Verification

Leverage existing automated software tests in your traceability. Integrate Aligned Elements into your continuous build chain and automatically export results from your automated software tests into Aligned Elements. 

Consulting Services

Deployment, Quick Start and Validation Services

If you need further help, we assist you with tasks such as:

  • Server installation support
  • Transfer support of existing documentation into Aligned Elements
  • Validation support
  • Advice on Design Control structuring
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Ask us for a tailored pricing quote!

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Other Aligned Elements Versions

Download Installation Setups and Support Tools 

Find current and previous versions of Aligned Elements and related applications below.


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Get in touch!

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Contact us

Aligned AG

Klingenstrasse 37
8005 Zürich
Switzerland

Office hours

09:00 - 18:00 CET

Phone

Email

  • Sales Information

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

  • Customer Information

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  • Company Information

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47.3821,8.5338

Aligned Office

Tellstrasse 31
8004 Zürich
Switzerland

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Aligned AG

We are Aligned. Our purpose is to assist our customers to develop innovative Medical Device in less time, using less resources.

Aligned was founded in 2006 by a team of experienced medical device developers with extensive and international background in the Life Science Industry. 

Our clients are manufacturers, end-customers and sub-suppliers in the medical device industry, companies who develop and market products which are subjects to regulatory compliance such as FDA Quality Systems Regulations or the EU MDD/MDR and IVDD/IVDR.

Our goal is to enhance our customer's capabilities in how to rapidly and successfully create quality compliant medical devices through excellence in regulatory documentation.

Our Story

"There must be an easier way to document than this!"

We loved developing medical devices!

Not only was it exciting (it still is!), innovative and creative. It also felt meaningful; doing something that could benefit the health of potentially thousands of patients and users. 

But then there was the documentation... It was always there – with us putting in endless hours on completing it, piling up as a vast mountain of binders.  It sometimes felt like we were spending more time documenting than innovating.  All we wanted to do was to develop devices and here we were, conducting frustrating, menial, repetitive documentation tasks.

We had fantastic, state-of-the-art engineering tools at our disposal, but for documentation we were stuck with Word and Excel.  The resulting work was as you could expect.  Auditors kept finding inconsistencies, errors and gaps and no matter how many times we reviewed our own documents, errors kept slipping through.  Our confidence in our own documentation work was ailing at best.

We were convinced that there must be a better way to handle the documentation work than the way we were doing it.  We were also convinced that medical device companies all over the world probably felt just the same way as we did.

In 2006, we started to work on Aligned Elements with the explicit goal to build a solution that could reduce the amount of work spent on development documentation while, at the same time, make sure that the resulting documentation was as error-free as possible.

Today, many years later, Aligned Elements has grown and expanded with the input from our customers, helping us to find smarter and better ways to reduce the documentation effort.  We keep a close eye on regulatory changes and the challenges they entail and always, always ask ourselves,  “how we can help our customers to become compliant with the least possible effort?”

At Aligned, we have our roots knee-deep in the everyday-life of medical device development and the documentation challenges that come with it. 

Like you, we want medical device development to be about innovation. Afterall, that is where your hard-earned expertise lies, where you can bring most value and, quite frankly, what you were hired to do!

What we do

Aligned provides Aligned Elements, an ALM system to ensure compliant development documentation for regulated products in the Medical Device Industry.

We assist our clients in developing, manufacture and market regulatory compliant products within shorter time-frames, to lower costs and with higher confidence.

At Aligned, we believe that management of product and project documentation of regulatory compliant products shall be efficient and pragmatic. We advocate an approach that allows your development team to focus on innovation instead of administration.

We strive to build value that last and therefore stay deeply involved with the undertakings of our clients until we are sure that sustainable results are achieved.

Request Trial Extension

If you did not get a chance to fully try out Aligned Elements or need a little more trial time to evaluate the product, simply enter your email address and click Submit to re-activate your Aligned Elements user.

You will be sent a confirmation email as soon as your user has been re-activated.

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Privacy Policy

Key Details

This privacy policy describes how Aligned AG protects and makes use of the information you give the company when you use this website.

If you are asked to provide information when using this website, it will only be used in the ways described in this privacy policy.

This policy is updated from time to time. The latest version is published on this page.

The website privacy policy was last updated on 2024-05-23

If you have any questions about this policy, please email This email address is being protected from spambots. You need JavaScript enabled to view it. or write to:

Privacy Policy
Aligned AG
Klingenstrasse 37
CH-8005 Zürich
Switzerland
Tel: +41 (0)44 312 50 20

Introduction

Aligned AG operates www.aligned.ch. We gather information about individuals in order to provide these individuals with information about our products and services.

We also collect information to better understand how visitors use this website and to present timely and relevant information to them.

What data we gather

We collect contact information from visitors, in the following situations, when they explicitly:

Request access to a demo version of Aligned Elements

Collected personal data: Name, Email, Company, (optional) telephone number

Request a quote from Aligned Elements

Collected personal data: Name, Email, Company, telephone number

Subscribes to our Blog/Newsletter updates

Collected personal data: Name, Email

Provides information about a bug or change request in Aligned Elements

Collected personal data: Name, Email

Register to one of our seminars

Collected personal data: Name, Email, Country, Company, Job title 

Browsing Information

We use Hotjar in order to better understand our users’ needs and to optimize this service and experience. Hotjar is a technology service that helps us better understand our users’ experience (e.g. how much time they spend on which pages, which links they choose to click, what users do and don’t like, etc.) and this enables us to build and maintain a relevant website. Hotjar stores this information on our behalf in a pseudonymized user profile. Hotjar is contractually forbidden to sell any of the data collected on our behalf. 

How we use the data

We use the collected contact information to provide the visitor with the information he/she has requested.

We also use the contact information to inform, upon their own request, visitors about product and service updates and upcoming seminars.

Cookies and how we use them

What is a cookie?

A cookie is a small file placed on your computer's hard drive. It enables our website to identify your computer as you view different pages on our website. Cookies allow websites and applications to store your preferences in order to present content, options, or functions that are specific to you. They also enable us to see information like how many people use a website and what pages they tend to view.

How we use cookies

We use cookies to analyse our web traffic using Google Analytics, Google Ads Conversion Tracking and Google Tag Manager. You will find more information concerning the treatment of user data by these Google tools in Google's Privacy Policy.

Cookies do not provide us with access to your computer or any information about you.

Our site has embedded YouTube videos.  When you visit a page with an embedded YouTube video, a connection to YouTube servers is established. This tells Youtube which pages you are visiting. If you are logged into your Youtube account, Youtube can assign your web usage behavior to you personally. You can prevent this by logging out of your Youtube account beforehand.

Our site uses the "LinkedIn Share Button". When you click on such a button, a connection is briefly established via the user's browser to servers of LinkedIn, with which the functions of the button, including the display of the count value, are performed. LinkedIn does not store any personal data of the user about the visit to the page, in particular no IP address is stored.

Our site uses Hotjar which uses cookies and other technologies to collect data on our users’ behavior and their devices. This includes a device's:

  • IP address (processed during your session and stored in a de-identified form)
  • device screen size
  • device type (unique device identifiers)
  • browser information
  • geographic location (country only),
  • the preferred language used to display our website.

Controlling cookies

The web site will let you choose to what extent cookies from our web site are stored on your computer. Use these settings as you see fit.
Further, you may prevent the collection of data generated by cookies (including your IP address) and related to the use of these websites, as well as the processing of such data by Google, by downloading and installing the plug-in under the following link: http://tools.google.com/dlpage/gaoptout?hl=en

To learn more about cookies and how they are used, visit All about cookies.

Controlling information about you

If you have agreed that we can use your information for the purposes stated in the forms you fill in, you can always change your mind at a later stage.

What are your privacy rights, and how can you exercise them?

You have the right to:

  • access your personal data and to be provided with certain information in relation to it, such as the purpose for which it is processed, the persons to whom it is disclosed and the period for which it will be stored
  • require us to correct any inaccuracies in your personal data without undue delay
  • require us to erase your personal data
  • require us to restrict processing of your personal data
  • receive the personal data which you have provided to us, in a machine readable format

Please note that these rights are not absolute and are subject to certain exemptions under applicable data protection law.

If you want to opt-out from the agreement or want us to delete your data, please notify us by emailing This email address is being protected from spambots. You need JavaScript enabled to view it. or write to:
Privacy Policy
Aligned AG
Klingenstrasse 37
CH-8005 Zürich
Switzerland

Who do we share your personal data with?

In some cases, we store your data for further processing. Depending on the purpose, we store them in our own secure systems (to handle demo requests, quote requests, bug requests or contact information), in Linkedin (to handle Event registration), in Hubspot and Sendgrid (to handle Newsletter subscriptions) or Hotjar for website analysis.

We will never lease, distribute or sell your personal information to third parties unless we are required to by law.

We may disclose personal data to public authorities, regulators or governmental bodies when required by law or regulation or if an authority or governmental body has issued an order requesting such personal data from us. Before we provide the information, we will inform you if the applicable law allows us to do so.

How long do we keep your personal data?

We only store personal data for as long as it is necessary to fulfil the purpose for which it was collected or to comply with legal or official requirements.

Security

No other users will see the information you have entered. To prevent unauthorized disclosure or access to your information, we have implemented strong physical and electronic safeguards. However, we may store Personal Information in locations outside our direct control (for instance, on servers or databases co-located with hosting providers).

Although we use Security Sockets Layer (SSL) encryption technology to encrypt sensitive personal information before it travels over the internet, remember that no method of transmission over the internet, or method of electronic storage is 100% secure. While we strive to use commercially acceptable means to protect your personal information, we cannot guarantee its absolute security.

Compromise of Personal Information

We will promptly notify those persons whose Personal Information is compromised. Notwithstanding, Aligned AG does not accept liability for any unintentional disclosure or a disclosure that occurs due to a security breach of our systems or facilities.

Data Protection Officer

Karl Larsson
Aligned AG
Klingenstrasse 37
CH-8005 Zürich
Switzerland
Tel: +41 (0)44 312 50 20