aligned elements Description

Aligned provides a purpose built eQMS and design management solution created exclusively for medical device and in vitro diagnostic manufacturers. It addresses the demands of global regulatory compliance while removing the friction typically associated with traditional QMS tools.

The system enables organizations to operate in line with key regulations and standards including ISO 13485, FDA QSMR, EU MDR, and IVDR. It is relied upon by experienced quality and development professionals who require transparency, control, and consistency across all stages of product development and post market activities.

Aligned brings quality management and design control together in a single coherent platform that supports cross functional teamwork. Quality, regulatory, R and D, and leadership teams work within the same controlled environment, where requirements, design data, verification and validation activities, risk files, and changes are inherently linked. This built in connectivity delivers complete traceability and clear evidence for audits, inspections, and regulatory submissions.

aligned elements Alternatives
Innoslate Reviews
Innoslate
(91 Ratings)
SPEC Innovations’ leading model-based systems engineering solution is designed to help your team minimize time-to-market, reduce costs, and mitigate risks, even with the most complex systems. Available as both a cloud-based and on-premise application, it offers an intuitive graphical user interface accessible through any modern web browser. Innoslate's comprehensive lifecycle capabilities include: • Requirements Management • Document Management • System Modeling • Discrete Event Simulation • Monte Carlo Simulation • DoDAF Models and Views • Database Management • Test Management with detailed reports, status updates, results, and more • Real-Time Collaboration And much more.
Learn more
Jama Connect Reviews
Jama Connect
(379 Ratings)
Jama Connect®, a product development platform, uniquely creates Living Requirements™. This digital thread is created through siloed, test, and risk activities to provide end to end compliance, risk mitigation, process improvement, and compliance. Companies creating complex products, systems, and software can now define, align, and execute on what they need. This reduces the time and effort required to prove compliance and saves on rework. You can be sure of success by choosing a solution that is easy-to-use, flexible, and offers support and services that are adoption-oriented.
Learn more
QVscribe Reviews
QVscribe
QRA’s tools streamline engineering artifact generation, evaluation, and prediction, refocusing engineers from tedious work to critical path development. Our solutions automate the creation of risk-free project artifacts for high-stakes engineering. Engineers often spend excessive time on the mundane task of refining requirements, with quality metrics varying across industries. QVscribe, QRA's flagship product, streamlines this by automatically consolidating these metrics and applying them to your documentation, identifying risks, errors, and ambiguities. This efficiency allows engineers to focus on more complex challenges. To further simplify requirement authoring, QRA introduced a pioneering five-point scoring system that instills confidence in engineers. A perfect score confirms accurate structure and phrasing, while lower scores prompt corrective guidance. This feature not only refines current requirements but also reduces common errors and enhances authoring skills over time.
Learn more
Modern Requirements4DevOps Reviews
Modern Requirements4DevOps
(4 Ratings)
Modern Requirements4DevOps is Microsoft's preferred partner for requirements management. It transforms Azure DevOps to a full-featured Requirements Management Tool. Your teams can come together on one platform to create a single source of truth model. Requirements are stored in the same place that your Test Cases or Code Repositories. Our tool supports agile, waterfall, and hybrid requirements by bringing reviews, end-to-end traceability, reporting, elaboration, modelling and more to Azure DevOps. Our robust requirements solution includes a leading feature set with project auditability.
Learn more

Pricing

Pricing Starts At:
€1300 per year
Pricing Information:
See: 'How to buy' on our homepage for the full offer
Free Trial:
Yes

Integrations

API:
Yes, aligned elements has an API
View Integrations

Reviews

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Company Details

Company:
Aligned AG
Year Founded:
2007
Headquarters:
Switzerland
Website:
www.aligned.ch/
Update This Listing

Media

Play Video aligned elements Screenshot 1 Traceability Chapter View Supplier Dashboard Suppliers CAPA Escalations
Recommended Products
Ship Agents Faster Icon
Ship Agents Faster

Transform your applications and workflows into powerful agentic systems at global scale.

Gemini Enterprise Agent Platform lets you rapidly build, scale, govern and optimize production-ready agents grounded in your organization's data. The platform enables developers to build custom or pre-built agents for virtually any use case. New customers get $300 in free credits.
Get Started Free

Product Details

Platforms
Web-Based
Windows
On-Premises
Types of Training
Training Docs
Live Training (Online)
In Person
Training Videos
Customer Support
Business Hours
Online Support

aligned elements Features and Options

Application Lifecycle Management Software

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 Software

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

aligned elements Lists

aligned elements User Reviews

Write a Review
  • Previous
  • Next