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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.

What is Orcanos?

Orcanos is a unified eQMS and ALM platform designed specifically for medical device companies that need to manage regulated product development and quality operations together. The platform helps R&D, Quality, Regulatory, and Operations teams work from a single source of truth instead of relying on disconnected documents, spreadsheets, and siloed systems. Orcanos connects design control, quality management, document control, risk management, requirements, testing, validation, training, and audit evidence across the full medical device lifecycle. Its eQMS capabilities support quality processes such as document approvals, revision control, electronic signatures, training automation, CAPA, complaints, audits, nonconformances, and compliance records. Its ALM and design control tools help teams manage user needs, design inputs, risks, mitigations, verification, validation, DHF documentation, and automated impact analysis. Orcanos supports key medical device compliance needs, including ISO 13485, EU MDR, ISO 14971, FDA expectations, and 21 CFR Part 11 requirements. The platform is built for adaptive compliance, allowing teams to configure workflows, forms, fields, status flows, permission structures, and approval processes without heavy coding. Document control features help automate lifecycle routing, publishing, archiving, read-and-understand training tasks, and audit trails for every revision. Risk management becomes a live process by linking hazards, requirements, mitigations, design changes, and verification evidence in real time instead of maintaining static Excel files. Orcanos also includes Ask Paul, an AI-powered assistant designed to help users work more efficiently across regulated quality and development activities. With rapid implementation, traceability, configurable workflows, and centralized compliance data, Orcanos helps medical device teams reduce regulatory friction, stay audit-ready, and bring safer products to market faster.

Media

Media

Integrations Supported

AgentMail
Amazon
Apollo
Claude Code
Composio
ContactOut
Didit
Gemini
GitHub
Klaus
Linkup
Openmart
Riveter
ScrapeGraphAI
Slack
X (Twitter)
YouTube
eBay
influencers.club

Integrations Supported

Salesforce

API Availability

Has API

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS
Android
Windows

Customer Service / Support

Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Orthogonal

Date Founded

2025

Company Location

United States

Company Website

www.orthogonal.com

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Categories and Features

Agentic AI

Not specified

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

Audit

Not specified

CAPA

Not specified

Compliance

Not specified

Document Control

Not specified

Quality Management

Not specified

Requirements Management

Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

Risk Management

Not specified

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