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Partners

Partners with us

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 LtdCommala 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-Ingstands 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

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The ISO 14971 risk management tool

The ISO 14971 Risk Management Tool

Stay ISO 14971 compliant and in control

More

Start your Free Trial now!

Would you like to ...

  • End-to-end Traceability

    Quickly reach compliance with ISO 14971 - Application of risk management to medical devices?

  • ISO

    Do risk analysis your way and not the way a tool prescribes it?

  • Continuous Traceability

    Automatically ensure that your mitigations are implemented?

  • Traceability Tables

    Use pre-configured Potential Hazards from ISO 14971?

  • Traceability Tables

    Monitor the effect of your mitigations in a pre- and post-mitigation Risk Summary?

  • UNMITIGATED

    Be warned if you have incomplete risk coverage or unmitigated risks?

  • LESS

    Spend less time on maintaining documents?

Reduce the time spent on Risk Management!

  • End-to-end Traceability

    By easily tracing ISO 14971 risk controls / mitigations to your design inputs

  • ISO

    By automating checks for not implemented mitigations

  • Continuous Traceability

    By checking the completeness of your risk management in seconds

  • Traceability Tables

    By re-using mitigations to save time and ensure consistency

  • Traceability Tables

    By using configurable (preliminary) hazard analysis (PHA) and FMEA in a single tool

  • PRESS

    By creating and updating your risk management files at the press of a button

Start using Aligned Elements!

  • Lower costs

    Lower costs for development

  • Minimize work

    Minimize the work on development documentation 

  • Free up personel

    Free up personel for innovation

  • Faster to the market

    Bring your Medical Devices to the market faster 

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The Art Of Medical Device Documentation

The Art Of Medical Device Documentation

  • document less
  • reach compliance fast

  • meet your goals

More

Get your Personal Online Demo!

And all of this in a single tool?

  • End-to-end Traceability

    Manage and Trace your Requirements

  • ISO

    Integrate your ISO 14971 compliant Risk Management 

  • Continuous Traceability

    Effectively manage and document your traceability matrix

  • Traceability Tables

    Define and execute Test Protocols

  • Traceability Tables

    Perform Design Reviews

No time to evaluate?

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!

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Complete End-to-end Traceability for your Medical Device

Complete End-to-end Traceability for your Medical Device

  • ISO compatible

  • continuous

  • automated

More

Request an online presentation now

What you get from Aligned Elements

  • End-to-end Traceability

    End-to-end Traceability over all Design Controls

  • ISO

    Integrate Traceability with ISO 14971 Risk Assessments

  • Continuous Traceability

    Continuous Traceability Quality Monitoring with graphical coverage

  • Traceability Tables

    Predefined Medical Device Traceability Tables for IEC 62304

  • Traceability Tables

    Automatically generated and synchronized traceability documentation

How Aligned Elements helps your company

  • Lower costs

    Lower costs for development

  • Minimize work

    Minimize the work on development documentation 

  • Free up personel

    Free up personel for innovation

  • Faster to the market

    Bring your Medical Devices to the market faster 

Continue reading

Customer Stories and White Papers

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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About the Author

White Paper

White Paper

Lorem Ipsum

New Video resources

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Accelerate your journey to CE Mark and FDA approval

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Try free Trial Thank you

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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Feel free to contact us if you have any questions.

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Customers

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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Extensions

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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Documentation

Support Documentation

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

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System Requirements

System Requirements

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)

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

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 Server

A prerequisite for the Aligned Elements Web Client

Web Server

Aligned Elements uses Microsoft IIS Web Server.

Version

IIS 8 or higher

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Request a live demo

Request a live demo

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