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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 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
Want to become a Partner?
Join our partner network to our customers bring world-leading Medical Devices to the market using Aligned Elements
The ISO 14971 risk management tool
The ISO 14971 Risk Management Tool
Stay ISO 14971 compliant and in control
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
The Art Of Medical Device Documentation
The Art Of Medical Device Documentation
- document less
reach compliance fast
- meet your goals
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!
Complete End-to-end Traceability for your Medical Device
Complete End-to-end Traceability for your Medical Device
ISO compatible
continuous
- automated
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
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
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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Accelerate your journey to CE Mark and FDA approval
Try aligned elements 30 days for free!
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.
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?
Still have questions about Aligned Elements?
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 |
Want to know more?
Try aligned elements for free and estimate your time saved.
Miscellaneous Support FAQ
Miscellaneous Support FAQ
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.
Word Support FAQ
Word Support FAQ
Documentation
Support Documentation
Dive into the rich feature set of Aligned Elements and smart solutions you can use to accelerate your Medical Device Development.
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.
Database Support FAQ
Database Support FAQ
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 |
Request a live demo
Request a live demo
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