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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
Composio
Fiber AI
Fundable
GitHub
Google Calendar
Microsoft 365
Notion
OpenClaw
Openmart
Riveter
Salesforce
ScrapeGraphAI
TikTok
Tomba
Walmart
X (Twitter)
eBay

Integrations Supported

AgentMail
Amazon
Apollo
Composio
Fiber AI
Fundable
GitHub
Google Calendar
Microsoft 365
Notion
OpenClaw
Openmart
Riveter
Salesforce
ScrapeGraphAI
TikTok
Tomba
Walmart
X (Twitter)
eBay

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

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

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

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Document Control

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Requirements Management

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

Risk Management

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment

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