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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 IMSXpress ISO 9001?

IMSXpress ISO 9001 is an all-encompassing software solution tailored for managing document control and quality systems effectively. The IMSXpress client can be installed on personal computers or a Windows server, which enables remote desktop services for user distribution as a remote application. It utilizes an MS SQL database that can be configured on any version starting from MS SQL Server 2014, allowing access to the IMSXpress application through various types of networks. For remote connectivity, users can establish their own network, opt for a cloud hosting service, or select an online subscription plan. The software also boasts an automated training module, which comprises self-training options, integrated document training, and comprehensive job descriptions, among other educational materials. Designed to accommodate modifications in documents, engineering, and processes, it allows users to create and fill PDF templates with ease, generating necessary records effortlessly. Furthermore, IMSXpress is instrumental in scheduling maintenance, managing spare parts inventory, and addressing complaints, non-conformities, risk assessments, and audit findings. This multifaceted nature of IMSXpress ensures that organizations not only uphold high quality management standards but also enhance their operational efficiency seamlessly. By integrating such a robust system, companies can foster continuous improvement and adapt to evolving industry demands with greater agility.

Media

Media

Integrations Supported

Jira
Microsoft 365
Salesforce

Integrations Supported

Microsoft Excel
SQL Server

API Availability

API Availability

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

$160 per month
Free Trial Offered?

Supported Platforms

SaaS
Android
Windows

Supported Platforms

SaaS
Windows

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
On-Site Training

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Company Facts

Organization Name

IMSXpress

Date Founded

1992

Company Location

Canada

Company Website

www.imsxp.com/00Home/IsoXpHome.aspx

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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