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Trial Form Test
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AE Accordion test
The ISO 14971 risk management tool
The ISO 14971 Risk Management Tool
Stay ISO 14971 compliant and in control
Start your Free Trial now!
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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
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Log in troubleshooting (Aligned Elements Web Client)
At first log in
If you are logging in for the first time and have problems, we have detailed instructions in the user manual.
The most common situations for not being able to log in for the first time are:
- Cannot find the activation email
- The link in the activation email has expired
- Error message "Invalid login attempt" at first log in
Click on the situation that applies to you for explanations and troubleshooting steps.
In General or after resetting your password
If you have log in problems in general or, e.g. after resetting your password, there are instructions and tips available here.
The most common situations for not being able to log in are:
- Error message "Invalid login attempt" at log in
- Locked out after too many tries
- The link in the Reset Password email has expired
- Not using the correct URL/Web address for your Aligned Elements installation
Where applicable, click on the situation that applies to you for explanations and troubleshooting steps.
Using High DPI settings / high screen resolutions
For an optimal display of the Aligned Elements windows client on high screen resolutions, use the "Override High DPI Settings"
How to do it:
1) Find the Aligned Elements shortcut
2) Display Properties (right-click on the short cut) => Compatibility Tab
3) At the bottom of the tab click "Change high DPI settings"
4) At the bottom of the displayed dialog, in the section "High DPI scaling override", tick the check box for "Override high DPI scaling" and select "System" (and not e.g. "System (Enhanced)") in the dropdown.
