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ISO 27001:2022 Certified

Security at Aligned

At Aligned AG, we know that security is paramount. Hundreds of medical device manufacturers rely on us to protect their information, and we take this responsibility with the utmost seriousness.

We meet global security standards 

GDPR/DSVO

Aligned AG is GDPR and DSVO compliant ensuring the required level of protection for personal data.

Our processes are aligned with Swiss and European data protection regulations, facilitating smoother operations across borders.

ISO 27001:2022

An ISO 27001 certification shows that Aligned AG has implemented structured processes to manage risks related to the security of data that Aligned owns or handles, and that these processes follow the best practices and principles defined by the international standard.

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FDA 21 CFR Part 11

The Aligned products are designed to support compliance with FDA 21 CFR Part 11. The platform includes technical controls for secure user authentication, role based access control, e-signatures and audit trails that ensure electronic records remain reliable and traceable.

Data Security

Secure Development

Aligned follows secure software development practices to protect the integrity of the platform, including controlled access, multi-layered verification, and security checks throughout the development lifecycle.

We regularly perform independent penetration testing to identify and address potential vulnerabilities.

Secure Access Control

Our products implements secure access controls through robust FDA 21 CFR Part 11 compliant user authentication, a multitude of security settings including optional 2FA.

Aligned supports single sign on (SSO) integration with Microsoft Entra, giving organizations flexible and strong control over who can access the system.

Secure Deployment

Aligned offers secure SaaS deployment with each customer hosted on a dedicated server, completely isolated from other customers.

Each customer also freely choose the geographical location of their system, ensuring data residency and compliance requirements are met.

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Get a quote designed to your needs!

Share your requirements with us, and we’ll prepare a personalized quote tailored to your unique medical device development situation.

The more details you provide, the better we can shape an offer that truly meets your needs.

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Genuine Voices, Tangible Results

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From Idea to Approval -
Accelerate the development
of your Medical Devices

Minimize the Technical Documentation efforts and speed up
the time-to-market with supercharged Design Control and eQMS Management.

Want to see it in action?

Book our sales team for a personal "guided tour". After we get your details, we will get back to you right away.

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Chosen by leading innovators

  • Coloplast

  • Align

  • Epredia

  • Vetter

  • Inspire

  • Enovis

Software for eQMS and Design Control Management.

We bring medical device companies the means to efficiently handle their quality, compliance and technical documentation tasks.

Design Control Management

Transform your Technical File writing

Unlock the massive potentials of Design Control-centric Technical Documentation building. Accelerate development and deliver complete, correct and consistent technical files.

Get Started

eQMS Quality Management

Quality that moves your Team forward

Automating and distributing quality tasks frees up time to focus on what matters. Continuously elevate your compliance level and stay ahead in a changing regulatory landscape.

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Where Innovation meets Quality

Develop and Document Medical Devices

For R&D Teams

AI-Driven Design Control Management that lets you focus on the real development! Generates consistent, complete and correct Technical Files with minimal effort.

Explore Aligned Elements

Manage Quality and Regulatory Compliance

For QA/RA Teams

Complete quality and regulatory tasks with ease to remain continuously compliant. Say goodbye to the nights and weekends spent prepping for audits and submissions.

Explore Aligned eQMS

Driving measurable improvements

  • 95%

    Of our customers experience an increased confidence in their Technical Documentation 

  • 90%

    Of our customers eliminated all missing traces with Aligned Elements

  • 85%

    Of our customers report high satisfaction with the Aligned solution.

  • 74%

    Of our customers experience an increased productivity with Aligned products

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Accelerate your journey to CE Mark and FDA approval

Try aligned elements 30 days for free!

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We are Aligned. Are you?

Time to innovate!

We started Aligned to give you more time. Time to bring life-changing medical devices to patients.

Reducing your burden of documentation and administration to get there faster, is our sole purpose.

If you want to focus on what you do best, we are the right choice.

Only Medical Devices!

All our customers create medical devices. This is the market we know and the only one we care about.

We monitor market trends closely, building new features in anticipation of regulatory change.

If you want to stay ahead of the curve, we are the right choice.

We are here for you!

How did we get here?

By listening.

Our products keep reaching new heights through direct and continuous collaboration with our customers.

If you want a say in the making of the tools you use, we are the right choice.

News, Events and Resources

  • New in Aligned Elements 3.2 - Join the Webinar

    2025-12-11

  • New Release - Aligned eQMS complements Aligned Elements

    2025-11-30

  • Innovation Without Disruption - Focus on Quality Management

    2025-11-15

  • Expert Secret #15-How to Tailor your Usability Engineering

    2025-10-27

Comply with Medical Device Standards & Regulations

  • ISO 13485:2016

    Our integrated eQMS and Design Control systems ensures alignment with ISO 13485 with controlled and auditable processes.

  • ISO 14971:2019

    Built to support all steps of medical device compliant risk assessments in our highly configurable design control system. 

  • IEC 62304:2015

    Medical Device Software development: supported and managed with our pre-defined IEC 62304 Design Control templates. 

  • FDA QSR 820

    With Quality Mgmt and Design Control capabilities designed for FDA QSR 820, your journey to US market access begins here.

  • EU MDR

    Kickstart your implementation for the european market with our GSPR requirement catalogue from the EU MDR Annex I.  

  • EU IVDR

    Hit the ground running and start your compliance journey with a ready-to-go GSPR checklist from the EU IVDR Annex I.  

  • IEC 60601-1

    Address essential electrical, mechanical, and environmental safety requirements with a system designed for IEC 60601-1.

  • IEC 62366:2015

    Connect your Use Scenarios and interface design to risk assessments, formative and summative testing in Aligned.

  • FDA QSR Part 11

    Our systems provide FDA QSR Part 11 compliant handling of electronic records and signatures, including audit trails & action monitoring.

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Customer Stories and White Papers

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

Customer Stories

White Papers

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More Best Practices and Lessons Learned? 

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.

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Get Started With a Free Trial Today!

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.

Thank you for your request of a trial.
We received your data and will send you an email with access information.

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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Still have questions about Aligned Elements?

Feel free to contact us if you have any questions.

Contact us

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Customers

we are proud to be trusted by companies around the world

...and many more

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

Company Instrument Category
Abbott Ablation Catheter
Abingdon Health Diagnostic Rapid Tests
AgenaBio Genotyping
AnchorDx Cancer genomics, genetics and bioinformatics
Anvajo Blood Analysis Instruments
AOT Cold Ablation Robot-guided Laser Osteotome
ASSKEA Aspirators
Athena Medical Medical Trolleys, Screens and Accessories
AVA Women Fertility Tracker
Bionano Optical genome mapping
Biotronik Implants
Bambi Medical Wireless monitoring devices
Benchmark Electronics Wireless Monitoring Systems
Biocartis Molecular Diagnostics
Baebies Medical Equipment Manufacturing
Bioscentia Laboratory Diagnostics
BoSonic Digital Asset Trading
BioRad Diagnostic Instruments
BIT Group Contract Development
Brighter Mobile Health
Cavidi HIV Diagnostics
Celon Pharma Integrated pharmaceutical company
Centerline Biomedical Endovascular Surgery Platform
CN Bio Innovation Organ-on-a-chip
CN Systems Hemodynamics
CorTec Neuro Implantable neurology products
Coloplast Wound care
Code Refinery Medical Device Engineering Consultants
CoMind Non-invasive neural sensors
CTC Diagnostics Sample Handling
Dawn Clinical, 4s Information Systems Medical Device Software
DATA Corp. Medical Device Software
Decision Sciences Medical Advanced Image Analysis
Diality Dialysis Machines
DJO Global Orthopedics, sports and health products
DNA Electronics Genomic Diagnostics
Dr Langer Medical Neuromonitoring, Neurostimulation
Ellex Ophtamology
Ergoline UV- & Lichttechnologie
Exciscope  X-Ray Microimaging
Emblation Microwave Therapy
Endosense Catheter ablation for the treatment of cardiac arrhythmias
Escatec Medical Device OEM Manufacturer
Everex Medical Device OEM Manufacturer
Exini Image Analysis
Ecomedics Online Medical Equipment
Figur8 Musculoskeletal health
Fluidic Protein Analysis
Fluidnet Infusion Systems
Fraunhofer-Institut für Biomedizinische Technik IBMT  Medical Device Prototyping
Geuder Devices for Ophthalmic surgery
Goal3 End-to-end clinical support system
Grossenbacher Systeme Control Display, Medical Electronics & EEMS
GratXRay Breast Cancer Imaging
Haughton Designs Medical Device Consultants
Heinemann Medical Technology ENT treatment and diagnostics
Hemotune Magnetic Blood Purification
IF Test Medical Device OEM Manufacturer
IH Medical IVF Solutions
Integrated Scientific Services Medical Device Engineering Consultants
Implantica Implant for prevention of gastroesophageal reflux
Inspire Medical Systems Neurostimulation Device
Sencure Bio- sensing wearable device
JawSense Tools for bruxism & TMD
Konplan Mechatronic and MedTech
KEYMKR Consultant Service Provider
Labitech Diagnostic Analysers
Lifelens Bio- sensing wearable device
Livetec Ingenieurbüro GmbH OEM Developers
Lohmann & Rauscher Wound Care, Opthalmology, OR Products
MBV Air samplers
Medyria Endovascular Catheters
Megin Brain Imaging
MPS AG Linear bearings and miniature ball screws
MinMaxMedical Surgical robotics and computer-assisted medical interventions
MIDI PD OEM Developers
Mycartis Analysis of Clinical Biomarkers
MyoSwiss Wearable Robotics
Mölnlycke Healthcare Wound Care
Nanocellect Cell sorters
Nanoomtech Automated External Defibrillator
NE Scientific LLC Medical Image Analysis, Modelling, Visualization
Nouvag Medical and Dental Powertools
Nuvia Healthtec Radiodiagnostics, radiotherapy, nuclear medicine and radiopharmacy
Oculox Technology Micro and laser technology
Oertli Instruments Ophtamology Therapy
Oculocare Eye health
Organ Assist Organ Perfusion Systems
Orthopediatrics Pediatric orthopedic instruments
Orlight Laser Surgical lasers
Osseointegrations Custom Implants
OstPunkt Medical Device Engineering Consultants
PA Consulting Medical Device Engineering Consultants
Pass Medical Device Consultants
Perimed Peripheral Vascular Diagnosis
Peripal Connection of dialysis tubings
Peter Lazic Microsurgical Instruments
Pjur Lubrications
Portal Instruments Needle Free Injections
Presidio IT Consultants
Promega DNA STR Analysis
PTW Dosimetry Radiation Therapy
QuantumDX Molecular Diagnostic Systems
Qiagen Molecular Diagnostics
RegenLife Neurotech and Photomedicine
Remp Sample Management
Rotarex S.A. High pressure valves, tube fittings and pressure regulators
Real Heart AB Heart and Lung machine
ReinVAD Modern Cardiac Support
SALTS Urostomy and Stoma care products
Scanco Medical CT Scanners
Schaer Proton Proton Therapy
Solve Medical Device Engineering Consultants
Sony Mobile Communications  Health Tech
Stilla PCR Systems
St Jude Medical Implantable Heart Pump
Storz Medical Shock wave therapy
Super Computing Systems Medical Device Engineering Consultants
T2Biosystems Blood test Instruments
Tecan Immunodiagnostics, Molecular Diagnostics
Thermo Scientific Tissue processing for anatomical pathology
Thermotek Thermal Therapy Solutions
Thoratec (Abbott) Heart Pumps
TMSi Measurement Systems for electrophysiological parameters
Universitätsklinikum RWTH Aachen  Medical Modelling
Varian Brachytherapy
Vectura Inhalation Devices
Vetter Pharma Aseptically pre-filled Application Systems
Vision Gate Software for 3-Dimensional Cell Imaging
Volpi Optoelectronic solutions
VOSS Healthcare Electronically assisted walkers
Xvivo Perfusion Transplantation Systems
Ziemer Ophthalmic Systems Ophthalmic Systems
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Accelerate your development with Free Extensions

Enhance Aligned Elements with over 50 available Extensions

Aligned Element Free 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.

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