Audience

Medical Device Manufacturers looking for a design control management solution

About aligned elements

Aligned eQMS and Aligned Elements Design Control software are built specifically for medical device and IVD companies that need to meet global regulatory requirements without unnecessary complexity.

The platform supports compliance with ISO 13485, FDA QSMR, EU MDR, and IVDR, and is trusted by experts that want full control over quality, design, and regulatory processes across the entire product lifecycle.

Aligned products, designed for collaboration between quality, regulatory, R&D, and management teams, combines a complete electronic Quality Management System with deep Design Control functionality in one fully integrated environment. Design inputs, outputs, verification, validation, risk management, and change control are natively connected to the QMS, ensuring end to end traceability that stands up to audits and inspections.

Pricing

Starting Price:
€1300 per year
Pricing Details:
See: 'How to buy' on our homepage for the full offer
Free Trial:
Free Trial available.

Integrations

API:
Yes, aligned elements offers API access

Ratings/Reviews

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features 0.0 / 5
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support 0.0 / 5

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Company Information

Aligned AG
Founded: 2007
Switzerland
www.aligned.ch/

Videos and Screen Captures

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Product Details

Platforms Supported
Cloud
Windows
On-Premises
Training
Documentation
Live Online
In Person
Videos
Support
Phone Support
Online

aligned elements Frequently Asked Questions

Q: What kinds of users and organization types does aligned elements work with?
Q: What languages does aligned elements support in their product?
Q: What kind of support options does aligned elements offer?
Q: What other applications or services does aligned elements integrate with?
Q: Does aligned elements have an API?
Q: What type of training does aligned elements provide?
Q: Does aligned elements offer a free trial?
Q: How much does aligned elements cost?
Q: What pricing for support is available for aligned elements?
Q: What pricing for training is available for aligned elements?

aligned elements Product Features

Application Lifecycle Management

Administrator Level Control Supported
Defect Tracking Supported
Release Management Supported
Requirements Review Supported
Task Management Supported
Test Case Tracking Supported
User Level Management Supported
Version Control Supported
Iteration Planning Not Supported
Project Management Not Supported

Requirements Management

Automated Requirements QA Supported
Automated Test Generation Supported
Change Management Supported
Collaboration Supported
History Tracking Supported
Prioritization Supported
Reporting Supported
Status Reporting Supported
Status Tracking Supported
Summary Reports Supported
Task Management Supported
To-Do List Supported
Traceability Supported
User Defined Attributes Supported
Automated Functional Sizing Not Supported
Automated Use Case Modeling Not Supported

aligned elements Additional Categories