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.
Other Popular Alternatives & Related Software
Matrix Requirements
For companies looking to accelerate development of their innovative medical device technologies, our Application Lifecycle Management and Quality Management Systems (eQMS) are easy-to-use, flexible, all-in-one software solutions designed to facilitate collaboration of employees on design control, and quality management to streamline medical device design.
Innovate faster with a flexible item-based approach to documentation designed to control even the most complex SxMD (Software as/in a Medical Device) product design.
Enhance quality management and ensure compliance with full traceability from design input to output with a purpose-built software platform that enables a collaborative quality culture across all teams.
Ensure frictionless alignment between platforms with native integrations for Jira, GitLab, GitHub, Azure DevOps and more.
Learn more
aqua cloud
aqua is an AI-powered advanced Test Management System designed to make the QA process painless. It is ideal for enterprises and SMBs across various sectors, although aqua was initially designed specifically for regulated industries like Fintech, MedTech and GovTech.
aqua cloud helps to:
- Organize custom testing processes and workflows,
- Run testing scenarios of any complexity and scale,
- Create extended sets of test data,
- Ensure thorough insights with rich reporting capabilities and
- Go from manual to automated testing smoothly.
Additionally, it includes a unique feature called “Capture," which transforms the process of documenting and reproducing bugs into a 1-click action.
aqua integrates with all the most popular issue trackers and automation tools like JIRA, Selenium, Jenkins and others. REST API is also available.
aqua's streamlines testing and saves your QA team up to 70% of time, enabling you to deliver high-quality software and releases x2 faster!
Learn more
QVscribe
QVscribe, QRA's flagship product, unifies stakeholders by ensuring clear, concise artifacts. It automatically evaluates requirements, identifies risks, and guides engineers to address them.
QVscribe simplifies artifact management by eliminating errors and verifying compliance with quality and industry standards.
QVscribe Features:
Glossary Integration: QVscribe now adds a fourth dimension by ensuring consistency across teams using different authoring tools. Term definitions appear alongside Quality Alerts, Warnings, and EARS Conformance checks within the project context.
Customizable Configurations: Tailor QVscribe to meet specific verification needs for requirements, including business and system documents. This flexibility helps identify issues early before estimates or development progress.
Integrated Guidance: QVscribe offers real-time recommendations during the editing process, helping authors effortlessly correct problem requirements and improve their quality.
Learn more
Modern Requirements4DevOps
Modern Requirements4DevOps turns Azure DevOps into a full-featured Requirements Management tool. Microsoft calls MR4DevOps its go-to partner for requirements management.
Bring your teams together under one platform to create a true single source of truth model where requirements live next to your Test Cases and code repositories. MR4DevOps is designed to bring many new features to Azure DevOps including:
• Robust requirements management, including curation, collaboration, and communication
• Authoring tools within ADO like SmartDocs and SmartReports
• Reviews
• End-to-end traceability
• Reporting
• Modelling
Modern Requirement4DevOps supports agile, waterfall, and hybrid requirements approaches. It includes an industry-leading feature set with complete project auditability.
Learn more
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/
Videos and Screen Captures
Other Useful Business Software
Gemini 3 and 200+ AI Models on One Platform
Build generative AI apps with Vertex AI. Switch between models without switching platforms.
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
