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.
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Pricing
Starting Price:
€1300 per year
Pricing Details:
See: 'How to buy' on our homepage for the full offer
Free Trial:
Free Trial available.
Company Information
Aligned AG
Founded: 2007
Switzerland
www.aligned.ch/
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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
aligned elements Product Features
Application Lifecycle Management
Administrator Level Control
Defect Tracking
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control
Iteration Planning
Project Management
Requirements Management
Automated Requirements QA
Automated Test Generation
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes
Automated Functional Sizing
Automated Use Case Modeling
