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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.

What is Merkely?

Merkely equips leading fintech firms with the tools necessary to oversee their continuously changing DevOps landscapes while ensuring adherence to compliance standards. It assures that your software development workflows and environments are always audit-ready through its relentless compliance strategies. By utilizing the skills of our DevOps experts, you can step confidently into the future of fintech, enjoying a smooth onboarding process into a state of continuous compliance. Gain extensive visibility through real-time reporting that encompasses both operations and compliance, guaranteeing thorough observability from start to finish. Improving your capability to monitor changes is possible by establishing a secure chain of custody throughout your development pipelines. The artifact log from Merkely utilizes cryptographic fingerprinting to create an unalterable identity for every binary produced during your controlled build operations. Additionally, it carefully records changes made to software delivery within your pipelines, creating an audit trail that fortifies security and risk management for each artifact involved. With Merkely, generating release approvals can be done effortlessly through version control, continuous integration, or even Slack notifications. You will enjoy compliant deployments that eliminate unnecessary complications, all while benefiting from streamlined processes that significantly boost overall productivity. This comprehensive approach ensures that every aspect of your DevOps environment aligns with regulatory requirements, fostering trust and reliability in your software solutions.

Media

Media

Integrations Supported

Jira
Microsoft 365
Salesforce

Integrations Supported

Slack

API Availability

API Availability

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

$1800 per month
Free Trial Offered?

Supported Platforms

SaaS
Android
Windows

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Online Training
On-Site Training

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Company Facts

Organization Name

Merkely

Company Location

Norway

Company Website

www.merkely.com

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

Categories and Features

Compliance

Not specified

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