Audience
Orcanos is best suited for medical device companies, MedTech startups, R&D teams, Quality teams, Regulatory Affairs teams, product development teams, and compliance leaders that need integrated eQMS, ALM, design control, risk management, document control, audit readiness, and traceability
About Orcanos
Orcanos is a medical device quality and development platform that unifies eQMS, ALM, design control, document control, and risk management in one system. It helps MedTech teams connect R&D and Quality workflows so requirements, risks, validations, documents, and audit evidence stay traceable. The platform supports compliance needs such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Orcanos includes customizable workflows, electronic signatures, document lifecycle automation, training tasks, audit trails, access controls, and centralized quality records. Its integrated ALM tools help teams manage design inputs, verification, validation, DHF readiness, impact analysis, and product development changes. With AI assistance, rapid deployment, and one source of truth for regulated product data, Orcanos helps medical device companies reduce compliance friction and accelerate innovation.
Other Popular Alternatives & Related Software
Interfacing’s Integrated Management System (IMS) is an AI-powered platform that unifies BPM, QMS, Document Control, and GRC into one platform. Organizations use IMS to model and automate processes, control documents, manage risks, and maintain regulatory compliance with full traceability and audit readiness.
Built for highly regulated sectors such as aerospace, life sciences, finance, and government, IMS provides real-time visibility, automated workflows, and AI-driven insights that improve quality and reduce operational risk. The platform is ISO 27001 certified and fully validated for 21 CFR Part 11, making it suitable for mission-critical environments requiring strong governance, security, and control. IMS also includes low-code automation, process mining, audit management, training tracking, CAPA workflows, and dashboards to help teams streamline operations and continuously improve. AI strengthens governance, improves accuracy, and reinforces regulatory control.
Learn more
Intelex is an integrated software solution for managing Environmental, Health, Safety and Quality (EHSQ) programs. Intelex’s scalable platform is designed to store, manage and analyze EHS and Quality data in one place. The solution works on any device to meet the realities of your workplace.
With Intelex, your organization can:
- Drive better results in your EHSQ program by monitoring workflows to achieve top performance and gain control.
- Identify trends and tendencies by setting goals to gain greater insight into your EHSQ program to enhance judgement.
- Reduce incidents and administrative work by easily monitoring, managing, optimizing and drawing insights from your safety data with our user-friendly safety software solution.
- Streamline air, water and waste emissions management and reporting, and track and manage environmental outputs to achieve sustainability goals.
- Drive continuous quality improvement activities across multiple departments, sites or locations.
Learn more
HSI Donesafe is a no-code, cloud-based EHS software that simplifies safety, compliance, and risk management, transforming complex processes into user-friendly workflows. Trusted by industries worldwide, Donesafe allows organizations to track, manage, and report on essential EHS functions from one central platform.
Our software adapts to your team’s style, enhancing everyday workflows with effortless compliance and smooth operations. Keep pace with evolving regulations and standards, from incident reporting and audits to training and risk assessments with Donesafe.
Unlock peace of mind with:
- Workflows that flex to meet ever-changing regulations
- Instant insights, keeping you confident in real-time safety tracking
- A scalable platform that grows in step with your team’s journey
- Simplified compliance that makes audits and reporting a breeze
Put safety at the heart of every day with HSI Donesafe; protect your team, simplify compliance, and ensure everyone goes home safe.
Learn more
AlisQI is a modular, cloud-based Quality Management platform for process and batch manufacturers who want to reduce firefighting, improve predictability, and stay compliant by default.
Unlike traditional EQMS platforms that were built around documents and later adapted for analytics, AlisQI was designed from the start as a data-first system. Quality, lab, and production data are structured and connected in one operational backbone.
That foundation now enables practical AI capabilities inside daily workflows. Manufacturers can automatically extract data from diverse supplier COAs without predefined templates, generate structured digital forms from existing files or plain language, query their QMS conversationally, and detect recurring incident patterns across sites.
Core modules include Document Control, Training, Deviations, CAPA, Audits, Risk Management, Supplier Quality, SPC, and EHS, supported by targeted out-of-the-box Solvers that address specific operational problems.
Learn more
Pricing
Free Version:
Free Version available.
Free Trial:
Free Trial available.
Integrations
Company Information
Orcanos
Founded: 2004
Israel
www.orcanos.com
Videos and Screen Captures
Other Useful Business Software
Ship Agents Faster
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.
Product Details
Platforms Supported
Cloud
Windows
Android
Training
Documentation
Live Online
Webinars
In Person
Support
Phone Support
Online
Orcanos Frequently Asked Questions
Orcanos Product 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
Requirements Management
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes
Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
