We know what we do best and what others do better than us. Our Partners make sure that Aligned Elements customers get maximum returns with minimal effort from our system by providing services, trainings, content and on-boarding assistance. 

Quality and Regulatory Experts

We team up with an array of Quality and Regulatory experts that can solve your Medical Device Development and Manufacturing issues on your terms.

Keymkr - Keymkr are experts in Compliance Engineering and Product Testing for Medical Devices (MD and IVD). Furthermore, Keymkr develops and market MEDULUS, a software extension for Aligned Elements. MEDULUS makes it possible to create and maintain standards-compliant development documentation throughout the entire life cycle of a medical device using Aligned Elements. Visit Keymkr

Qadvis - QAdvis is a team of expert advisors in compliance, quality and productivity for the MedTech industry. We work with MedTech quality and system management, risk management, compliance, training, interim management and regulatory affairs. Visit Qadvis

ISS - ISS AG provides services for the development of medical devices, their introduction into the market and their maintenance. Typical services include embedded software development, regulatory affairs and clinical evaluation report writing, clinical research, quality management, qualification and validation. Visit ISS

Medidee - Medidee is your partner for medical devices and IVD compliance in Europe and USA. Medidee provides the necessary competencies internally to handle all aspects of your project, from the Design to the Certification. Visit Medidee

Inmedis - Inmedis connects IT and processes. Their services and know how include Regulatory Affairs, Quality Management, QM IT systems, Technical Documentation, Biocompatibility and Computer System Validation. Visit Inmedis

Commala Ltd - Commala offers a service that spans Medical Device Engineering, Regulation and Quality. From the big picture to the devil in the detail; Commala’s hands-on and pragmatic approach to development and engineering is aimed at helping your team get the most out of their assets. Visit Commala

IPP - IPP offers specialized services for medical devices manufacturers in all relevant areas to comply with MDR 2017/745. IPP provides the tool “Easy13485 QMS Software as Service,” to access your process landscape with binding and efficient instructions and the control of ISO 13485 compliance together with a standard-compliant and already filled quality management system. This saves both time and money to get started with your QMS right away. Visit IPP

Usability Experts

For assistance by and access to Human Factors / Usability / IEC 62366 Experts with Aligned Elements experience, reach out to our partners.

Use-Ing - stands for usability engineers and at the same time expresses that our focus is always on representative users and their interaction with various technical products in the respective context of use. Use-Ing successfully supports companies in the medical technology, aeronautical engineering, software engineering, mechanical engineering, mobile machinery and geronto-technology sectors in the human-centered technology development of interactive systems. Visit Use-Ing

Umbrella UX - With our human factors and usability engineering competencies, we support companies in safety-relevant industries to minimize usage-related risks in their products, workflows or processes in order to avoid undesired events such as accidents or product recalls. Visit Umbrella UX

Educational Institution, Clusters and Cooperations

Aligned Elements is used at educational institutions where medical device development is taught.

Hochschule Furtwangen - Aligned Elements is used in the education of medical device at HS Furtwangen, teaching the concepts of Design Control Management. Visit HS Furtwangen

Swiss Medtech - Swiss Medtech is the association of Swiss medical technology, representing around 700 companies. We work closely with our members, informing them of essential developments and supporting them in the event of challenges. Aligned is a member of Swiss Medtech. Visit Swiss Medtech

Health Tech Cluster Switzerland - Health Tech Cluster is a network of manufacturers, suppliers, research and training institutions, service providers and investors in the health technology sector. Aligned is a member of the Health Tech Cluster. Visit the Health Tech Cluster

MDKU - Medical Device Knowledge Units (MDKU) is a non-profit organisation that develops an open source data model for the technical documentation of medical devices to speed up digitalization. Visit MDKU

Join our partner network to our customers bring world-leading Medical Devices to the market using Aligned Elements 

Stay ISO 14971 compliant and in control

If you cannot spare the time to do your own evaluation, let us show Aligned Elements to you in a personal online demo!

This takes about 60 minutes and afterwards you know what Aligned Elements can do for you.

The online demo can also be an efficient kick-start for your own evaluation.

So go ahead and schedule a demo with us!

Customer Stories and Design Control Management Best Practices and Lessons drawn from hundreds of Medical Device Development Cases.

Sign up with us and be the first one to get new resources and blog posts on Best Practices, Lessons Learned and implications of Regulatory updates.

What you get for free:

• 30 days free trial
• Access to Web and Windows clients
• Medical Device example project 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?

• Licensing
• User Manual
• EULA

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.

Feel free to contact us if you have any questions.

to join our growing list of customers using aligned elements to save time and focus on the interesting part of developing medical devices.

Try aligned elements for free and estimate your time saved.

Enhance Aligned Elements with over 50 available Extensions

Explore our preconfigured extensions, made available to complete your Technical Documentation faster. Extensions are free add-ons to Aligned Elements that can be downloaded and integrated into your Aligned Elements configuration/projects.

We have made these extensions available for download to speed up your work. Use them to save time, increase transparency or improve the quality of your Design History File. Contact our support for more information on how to deploy and use these extensions.

Dive into the rich feature set of Aligned Elements and smart solutions you can use to accelerate your Medical Device Development.

Sign up with us and be the first one to get new resources and blog posts on Best Practices, Lessons Learned and implications of Regulatory updates.

Try Aligned Elements, the Medical Device ALM, and experience how world-class Design Control Management will accelerate your Technical File / Design History File completion.

What you get for free:

• 30 days free trial
• Access to Web and Windows clients
• Medical Device example project included
• Free technical support

No Credit Card needed!

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

Need to know more?

• Licensing
• User Manual
• EULA

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.

Feel free to contact us if you have any questions.

Start a free 30-days trial today!

Find out more about license types, deployment options, discounts and value packages below!

Node-locked

1300 €

yearly fee

Dedicated to a particular computer
For intensive use

Includes free upgrades and support.

Floating

Popular

2400 €

yearly fee

Shared on any number of computers
For flexible use

Includes free upgrades and support.

Reviewer

750 €

yearly fee

Floating viewer licenses
For reading, reviewing and signing

Min. Quantity: 5
Only for Web Client

Floating licenses are great for users that occasionally work on Aligned Elements whereas Node-locked licenses are the obvious choice for dedicated users.

Since floating licenses are shared among several team members, the actual team cost decreases as the team size increases.

For advice on best possible license mix, contact us and request a quote. For starting your Free Trial of Aligned Elements, continue here.

We offer tier-based volume discounts starting from the 6th license. The discount per tier applies on the licenses in that tier.
Contact our sales department for any questions on our volume discounts.

If our On-Premise or private Cloud deployment options seems like too much hassle, Aligned Elements as Hosted solution is the perfect substitute. The same license types as listed above are used to when access in the Hosted Solution with the additional condition of a minimum number of active licenses required. Aligned Elements as Hosted Solution allows the user to access our Cloud-based repository using the Aligned Elements Web Client.

The Aligned Elements as Hosted Solution Service Level agreement details are listed here.

Named

130 € / license

monthly cost

(based on yearly
fee of 1560 €)

Minimum 10 licenses

Includes free updates, monitoring and support.

Floating

Popular

250 € / license

monthly cost

(based on yearly
fee of 3000 €)

Minimum 5 licenses

Includes free updates, monitoring and support.

Reviewer

65 € / license

monthly cost

(based on yearly
fee of 780 €)

Minimum 5 licenses

For reading, reviewing and signing.

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:

Ask us for a tailored pricing quote!

Worldclass Design Control Management will accelerate your Technical File / Design History File completion 

Globally Trusted By

Try aligned elements 30 days for free!

Biotronik connects the dots

user story

New Customer Story

From duplicated work, manual tracking and the looming risks of documentation inconsistencies to integrated, comprehensible Design Control Management.

Read more about how Biotronik streamlined their Design Control Management using Aligned Elements.

Aligned Elements capabilities helps you to stay in compliance with standards and regulations essential to medical device development.

We continously monitor the regulatory landscape to addresses your emerging compliance challenges in upcoming releases.