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What is aligned elements?

Aligned offers an integrated eQMS and design control for medical device and IVD organizations. The solution is engineered to help companies satisfy international regulatory expectations in a structured and efficient way, without adding unnecessary operational burden. The software aligns with major regulatory frameworks such as ISO 13485, FDA QSMR, EU MDR, and IVDR. It is used by professional teams who need reliable oversight of quality activities, product development, and regulatory documentation throughout the full lifecycle of their products. By uniting electronic quality processes and design control in one system, Aligned enables seamless collaboration across quality assurance, regulatory affairs, research and development, and executive functions. Product requirements, design records, verification and validation evidence, risk management activities, and controlled changes are inherently connected, providing continuous traceability and defensible documentation during audits and inspections.

What is Tandem?

Tandem offers a robust software solution aimed at hardware engineering, effectively linking product requirements with CAD design tasks while integrating review contexts and validation documentation. With its specialized requirements workspace, teams can efficiently categorize and manage requirements, which allows for straightforward monitoring of design updates and relevant supporting materials. By connecting with CAD platforms, Tandem captures essential design discussions, helping engineers understand the rationale behind modifications. Furthermore, teams have the capability to link review input to specific requirements, CAD modifications, and engineering decisions, while evaluating the impact of changes as the designs evolve. Designed specifically for hardware teams involved in developing complex products across diverse sectors such as aerospace, medical technology, robotics, automotive, and industrial machinery, Tandem works in harmony with existing CAD, PDM, and PLM systems. This seamless integration guarantees that mechanical, systems, and quality engineers have continuous access to design intent and technical context throughout the development and review phases. Ultimately, Tandem not only boosts collaboration and transparency among teams but also plays a vital role in ensuring the effective execution of intricate engineering projects, fostering innovation and efficiency in product development.

Media

Media

No images available

Integrations Supported

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine

Integrations Supported

Autodesk Fusion
Google Sheets
Jama Connect
Jira
Microsoft Excel
Microsoft Teams
Onshape
SOLIDWORKS
Slack

API Availability

Has API

API Availability

Pricing Information

€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Trial Offered?

Pricing Information

Pricing not provided

Supported Platforms

SaaS
Windows
On-Prem

Supported Platforms

SaaS
On-Prem

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Not specified

Training Options

Documentation Hub
Online Training
On-Site Training

Training Options

Not specified

Company Facts

Organization Name

Aligned AG

Date Founded

2007

Company Location

Switzerland

Company Website

www.aligned.ch/

Company Facts

Organization Name

Tandem Intelligence Inc.

Date Founded

2025

Company Location

United States

Company Website

tandem.inc

Categories and Features

Application Lifecycle Management

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

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

Categories and Features

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