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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 FlinkISO?

FlinkISO's Quality Management System (QMS) stands out as a highly favored software option for small and medium enterprises. It seamlessly integrates with ONLYOFFICE editors, enabling users to design personalized HTML forms that meet the specific needs of their QMS documents. Remarkably, you can develop your own QMS without needing any coding skills or technical expertise. The software comes equipped with various essential modules, including Audit Management, Customer Complaints, Document Management, and Change Control, among others. Additionally, the intuitive drag-and-drop feature allows for easy incorporation of custom business rules, email notifications, and supplementary HTML fields. FlinkISO offers versatile and budget-friendly payment plans for both on-premise and cloud-based applications. Users opting for the cloud version benefit from a generous 45-day free trial, while the on-premise version is priced at USD80 per month. This combination of features and affordability makes FlinkISO a compelling choice for businesses looking to enhance their quality management processes.

Media

Media

Integrations Supported

Jira
Microsoft 365
Salesforce

Integrations Supported

ONLYOFFICE Docs

API Availability

API Availability

Has API

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

$80.00/month
Available on-premise and on-Cloud. On-Premise Lite & Enterprise versions.
Free Version
Free Trial Offered?

Supported Platforms

SaaS
Android
Windows

Supported Platforms

SaaS
iPhone
iPad
Windows
Mac
On-Prem
Linux

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Company Facts

Organization Name

Techmentis Global Services

Date Founded

2012

Company Location

India

Company Website

www.flinkiso.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

Document Control

Change Management
Compliance Management
Periodic Review
Version Control

Document Management

Access Controls
Collaboration Tools
Document Archiving
Document Indexing
Forms Management
Version Control

Quality Management

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

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