aligned elements

aligned elements

Aligned AG
+
+

Related Products

  • Jama Connect
    416 Ratings
    Visit Website
  • Gemini Enterprise Agent Platform
    1,161 Ratings
    Visit Website
  • Serviceaide
    244 Ratings
    Visit Website
  • ActiveCampaign
    17,400 Ratings
    Visit Website
  • Anaconda
    625 Ratings
    Visit Website
  • StackAI
    55 Ratings
    Visit Website
  • XpertCoding
    42 Ratings
    Visit Website
  • Predict360
    18 Ratings
    Visit Website
  • AlsoThere
    1 Rating
    Visit Website
  • SearchUnify
    150 Ratings
    Visit Website

About

Orthogonal provides specialized development services focused on building and scaling Software as a Medical Device (SaMD) and connected medical device systems, combining modern engineering practices with strict regulatory compliance. Their approach spans the full product lifecycle, including user experience design, human factors integration, requirements definition, risk analysis, Agile software development, and verification and validation to ensure both functionality and safety. It emphasizes the use of Agile methodologies adapted to regulated environments, enabling iterative development, faster feedback cycles, and continuous improvement while maintaining compliance with standards such as FDA, EU MDR, and ISO frameworks. Orthogonal supports the development of mobile, web, and desktop applications, cloud-based systems, AI algorithms, and SDKs that integrate with third-party platforms, allowing medical devices to connect, process data, and deliver insights.

About

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.

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Medical device companies, digital health startups, and healthcare technology teams that need to develop compliant, scalable software for connected medical devices and digital therapeutics

Audience

Medical Device Manufacturers looking for a design control management solution

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Pricing

€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Version Not Supported
Free Trial Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Company Information

Orthogonal
Founded: 2025
United States
www.orthogonal.com

Company Information

Aligned AG
Founded: 2007
Switzerland
www.aligned.ch/

Alternatives

Alternatives

ReqView

ReqView

Eccam
EagleView

EagleView

EagleView Technologies
ZipQuality

ZipQuality

Consensia
Kovair ALM-PLM CoE

Kovair ALM-PLM CoE

Kovair Software
STL Simple Viewer

STL Simple Viewer

Victor Bovio
Kovair ALM

Kovair ALM

Kovair Software

Categories

Agentic AI Supported

Categories

Application Lifecycle Management Features

Administrator Level Control Supported
Defect Tracking Supported
Iteration Planning Not Supported
Project Management Not Supported
Release Management Supported
Requirements Review Supported
Task Management Supported
Test Case Tracking Supported
User Level Management Supported
Version Control Supported

Requirements Management Features

Automated Functional Sizing Not Supported
Automated Requirements QA Supported
Automated Test Generation Supported
Automated Use Case Modeling Not Supported
Change Management Supported
Collaboration Supported
History Tracking Supported
Prioritization Supported
Reporting Supported
Status Reporting Supported
Status Tracking Supported
Summary Reports Supported
Task Management Supported
To-Do List Supported
Traceability Supported
User Defined Attributes Supported

Integrations

GitHub Supported
Amazon Supported
Apollo Supported
Claude Code Supported
Crustdata Supported
Didit Supported
Gemini Supported
GitLab Not Supported
Jira Align Not Supported
Klaus Supported
Linkup Supported
Nano Banana Supported
Notion Supported
Redmine Not Supported
Riveter Supported
Tomba Supported
Walmart Supported
X (Twitter) Supported
eBay Supported
influencers.club Supported

Integrations

GitHub Supported
Amazon Not Supported
Apollo Not Supported
Claude Code Not Supported
Crustdata Not Supported
Didit Not Supported
Gemini Not Supported
GitLab Supported
Jira Align Supported
Klaus Not Supported
Linkup Not Supported
Nano Banana Not Supported
Notion Not Supported
Redmine Supported
Riveter Not Supported
Tomba Not Supported
Walmart Not Supported
X (Twitter) Not Supported
eBay Not Supported
influencers.club Not Supported
Claim Orthogonal and update features and information
Claim Orthogonal and update features and information
Claim aligned elements and update features and information
Claim aligned elements and update features and information