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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 ALMXpert?

We understand the challenges you encounter across different business sectors and strive to resonate with your organization's fundamental values. Our approach, centered around delivering value, is designed to help clients quickly introduce a streamlined product to the market. We take great pride in elevating our clients' offerings through a steadfast commitment to openness, swift turnaround times, and continual quality assurance throughout the entire development process. Our ultimate aim is to produce a superior-quality product. The transition from product conception to final delivery is carefully structured using the best practices of the Software Development Life Cycle (SDLC), ensuring that users benefit from an exceptional experience alongside clean, efficient, and scalable code. To uphold high standards, each element of the codebase is protected by automated testing. Our transparent and honest advisory services focus on enhancing your product's acceptance in the market while effectively reducing overhead costs, empowering you to make prudent investments. Additionally, our experienced technical specialists are prepared to help you mitigate technical debt with cost-effective solutions, allowing you to draw in a larger customer base without excessive spending. With our unwavering support, your product is poised to excel in an increasingly competitive environment. We are committed to your success and look forward to fostering a collaborative partnership that drives innovation.

Media

Media

Integrations Supported

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine

Integrations Supported

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine

API Availability

Has API

API Availability

Has API

Pricing Information

€1300 per year
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Aligned AG

Date Founded

2007

Company Location

Switzerland

Company Website

www.aligned.ch/

Company Facts

Organization Name

TalentXpert

Date Founded

2000

Company Location

India

Company Website

talentxpert.com

Categories and Features

Application Lifecycle Management

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

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

Categories and Features

Application Lifecycle Management

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

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