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What is objectiF RPM?

Enterprise software designed to enhance business agility encompasses several key features, such as objectiF RPM, which includes management tools for portfolios, requirements, tests, and risks. With the ability to create UML/SysML diagrams, users can effectively visualize their requirements, objectives, and processes in a clear manner. Additionally, it facilitates backlog management across various levels, including business use cases and user stories, while offering task planning through Kanban boards and the capability to execute queries across multiple projects. This integrated approach fosters collaboration among distributed teams, all relying on a single source of information. Furthermore, the software is highly customizable, allowing it to adapt to specific corporate needs while maintaining flexibility, extensibility, and integration options. It also offers templates tailored for agile methodologies, mixed project management, digitization initiatives, and frameworks adhering to the Scaled Agile Framework® (SAFe), ensuring that organizations can effectively manage their projects in a dynamic environment. By leveraging these comprehensive features, businesses can significantly boost their operational efficiency and responsiveness to market changes.

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

Jira
Microsoft Excel
Microsoft Project
Microsoft Visio
Microsoft Word

Integrations Supported

Jira
Microsoft 365
Salesforce

API Availability

Has API

API Availability

Pricing Information

129 €/month/concurrent user
Free Trial Offered?

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Supported Platforms

Windows

Supported Platforms

SaaS
Android
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
Online Training
On-Site Training

Company Facts

Organization Name

microTOOL

Date Founded

1984

Company Location

Germany

Company Website

www.microtool.de/en/products/objectif-rpm/

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Categories and Features

Application Lifecycle Management

Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control

Enterprise Architecture

Architecture Governance
Modeling & Simulation
Project Management
Version Control

IT Project Management

Bug Tracking
Milestone Tracking
Percent-Complete Tracking
Portfolio Management
Prioritization
Product Roadmapping
Requirements Management
Resource Management
Status Tracking
Supports Agile
Supports Scrum
Task Management
Testing / QA Management
Time & Expense Tracking

Quality Management

Compliance Management
Document Control
Risk Management

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

Compliance Management
Dashboard
IT Risk Management
Internal Controls Management
Risk Assessment

Test Management

Collaboration Tools
Reporting / Analytics
Requirements Management
Test Tracking
Time/Budget Tracking

Workflow Management

Access Controls/Permissions
Compliance Tracking
Configurable Workflow
Customizable Dashboard
Document Management
Forms Management
Graphical Workflow Editor
Task Management
Workflow Configuration

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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