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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 Orthogonal?

Orthogonal focuses on providing specialized development services aimed at the design and growth of Software as a Medical Device (SaMD) along with interconnected medical device systems, merging advanced engineering practices with a strong commitment to regulatory compliance. Their approach encompasses the full spectrum of the product lifecycle, incorporating aspects such as user experience design, integration of human factors, requirement specification, risk assessment, Agile software development, and meticulous verification and validation procedures to ensure both safety and operational efficiency. By applying Agile methodologies specifically adapted for regulated environments, they enable iterative development, foster rapid feedback cycles, and support continuous improvements while maintaining adherence to regulatory guidelines such as the FDA, EU MDR, and ISO standards. Additionally, Orthogonal supports the creation of a variety of applications, including mobile, web, and desktop solutions, as well as cloud-based systems, artificial intelligence algorithms, and SDKs that facilitate integration with third-party platforms, allowing medical devices to connect effortlessly, analyze data effectively, and deliver critical insights. This all-encompassing strategy not only leads to innovative solutions that comply with industry benchmarks but also significantly improves patient care and enhances operational productivity, ultimately benefiting healthcare providers and patients alike.

Media

Media

Integrations Supported

GitHub
Redmine

Integrations Supported

GitHub
AgentMail
Amazon
Claude Code
ContactOut
Crustdata
Cursor
Didit
Fiber AI
Fundable
Nano Banana
Notion
OpenAI Codex
OpenClaw
Openmart
Riveter
Tavily
YouTube
influencers.club

API Availability

Has API

API Availability

Has API

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

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub
Online Training
On-Site Training

Training Options

Documentation Hub

Company Facts

Organization Name

Aligned AG

Date Founded

2007

Company Location

Switzerland

Company Website

www.aligned.ch/

Company Facts

Organization Name

Orthogonal

Date Founded

2025

Company Location

United States

Company Website

www.orthogonal.com

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

Agentic AI

Not specified

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