aligned elements Description

Aligned provides a purpose built eQMS and design management solution created exclusively for medical device and in vitro diagnostic manufacturers. It addresses the demands of global regulatory compliance while removing the friction typically associated with traditional QMS tools.

The system enables organizations to operate in line with key regulations and standards including ISO 13485, FDA QSMR, EU MDR, and IVDR. It is relied upon by experienced quality and development professionals who require transparency, control, and consistency across all stages of product development and post market activities.

Aligned brings quality management and design control together in a single coherent platform that supports cross functional teamwork. Quality, regulatory, R and D, and leadership teams work within the same controlled environment, where requirements, design data, verification and validation activities, risk files, and changes are inherently linked. This built in connectivity delivers complete traceability and clear evidence for audits, inspections, and regulatory submissions.

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Pricing

Pricing Starts At:
€1300 per year
Pricing Information:
See: 'How to buy' on our homepage for the full offer
Free Trial:
Yes

Integrations

API:
Yes, aligned elements has an API
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Company Details

Company:
Aligned AG
Year Founded:
2007
Headquarters:
Switzerland
Website:
www.aligned.ch/
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Product Details

Platforms
Web-Based
Windows
On-Premises
Types of Training
Training Docs
Live Training (Online)
In Person
Training Videos
Customer Support
Business Hours
Online Support

aligned elements Features and Options

Application Lifecycle Management Software

Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control

Requirements Management Software

Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

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