aligned elements

aligned elements

Aligned AG
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About

Requirements Portal by Altium is a requirements management and verification tool integrated directly into Altium’s solutions, including Altium Develop, Altium Agile Teams and Altium Agile Enterprise. It enables engineering teams developing hardware products and embedded systems to create, store, and manage formalized requirements and link them to designs and verification data. Each requirement is traceable and connected to upstream system definitions and downstream design and verification artifacts, such as schematics, PCB layouts, BOMs, and test cases, providing visibility from system design through implementation, verification, handoff, and certification. This helps teams reduce rework, avoid misalignment across disciplines, and simplify compliance activities.

About

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.

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

System, hardware, electronics and embedded software engineering team developing hardware products and embedded systems seeking to manage formalized requirements with end-to-end traceability.

Audience

Medical Device Manufacturers looking for a design control management solution

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

Requirements Portal is included in Altium Develop with unlimited collaborators. Create an Altium Develop workspace for $995/year. Invite unlimited collaborators for free.
Free Version Not Supported
Free Trial Supported

Pricing

€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Version Not Supported
Free Trial Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Company Information

Altium
Founded: 1985
United States
www.altium.com/capabilities/requirements/requirements-management

Company Information

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

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Categories

Categories

Requirements Management Features

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

Product Data Management Features

Bill of Material Management Not Supported
Document Management Supported
Formula Management Not Supported
Product Analytics Not Supported
Product Lifecycle Management Not Supported
Testing Management Supported
Version Control Supported

Product Lifecycle Management Features

Change Management Supported
Compliance Management Supported
Cost Tracking Not Supported
Design Management Not Supported
Document Management Supported
Product Data Management Not Supported
Project Management Not Supported
Requirements Management Supported
Supplier Management Not Supported

Test Management Features

Automation Integration Not Supported
Collaboration Tools Not Supported
Pass/Fail Results Tabulation Supported
Reporting / Analytics Supported
Requirements Management Supported
Test Scheduling Supported
Test Tracking Supported
Time/Budget Tracking Supported

Requirements Management Features

Automated Functional Sizing Not Supported
Automated Requirements QA Supported
Automated Test Generation Supported
Automated Use Case Modeling Not 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

Application Lifecycle Management Features

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

Integrations

Altium Develop Supported
Apache Subversion Not Supported
Azure DevOps Server Not Supported
GitHub Not Supported
GitLab Not Supported
Jira Align Not Supported
Redmine Not Supported

Integrations

Altium Develop Not Supported
Apache Subversion Supported
Azure DevOps Server Supported
GitHub Supported
GitLab Supported
Jira Align Supported
Redmine Supported
Claim Requirements Portal and update features and information
Claim Requirements Portal and update features and information
Claim aligned elements and update features and information
Claim aligned elements and update features and information