objectiF RPM

objectiF RPM

microTOOL
+
+

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About

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.

About

Enterprise software for enhanced business agility. objectiF RPM offers features for project, portfolio, requirements, test, risk and workflow management. Visualize requirements, goals and processes with UML/SysML diagrams, manage backlogs on different levels of granularity (from business use case to user story), define workflows and patterns for recurring set-ups, plan taskmanagement with Kanban boards, run queries across multiple projects and collaborate efficiently with distributed teams on one single source of information. The software is highly customizable, integrable and extensible and can be specifically tailored to your individual corporate needs. It offers templates for agile and hybrid project management, digitization programs and projects following the Scaled Agile Framework®, SAFe.

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Supported
Chromebook Not Supported

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Not Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

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

Audience

Organizations who want to increase agility without giving up on compliance

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version Supported
Free Trial Supported

Pricing

129 €/month/concurrent user
Free Version Not Supported
Free Trial Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

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Reviews/Ratings

Overall 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 5.0 / 5
support 5.0 / 5

Pros & Cons from Real Users

Pros

  • + Graphic representation of linked artefacts (i.e. use cases, concept diagram, etc.) + Configurability + Competitive Price (invest + operation) + Easy-to-learn product structure

Cons

  • + Customising the templates for document generation requires a detailed understanding of the feature + Updating and maintaining the self-hosted software requires a good amount of IT knowledge, especially when the video-conferencing feature first arrived

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Company Information

Orcanos
Founded: 2004
Israel
www.orcanos.com

Company Information

microTOOL
Founded: 1984
Germany
www.microtool.de/en/products/objectif-rpm/

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Categories

Categories

Application Lifecycle Management Features

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

Requirements Management Features

Automated Functional Sizing Not Supported
Automated Requirements QA Not Supported
Automated Test Generation Not Supported
Automated Use Case Modeling Not Supported
Change Management Supported
Collaboration Supported
History Tracking Supported
Prioritization Supported
Reporting Supported
Status Reporting Supported
Status Tracking Supported
Summary Reports Supported
Task Management Supported
To-Do List Supported
Traceability Supported
User Defined Attributes Supported

Application Lifecycle Management Features

Administrator Level Control Not Supported
Defect Tracking Supported
Iteration Planning Supported
Project Management Supported
Release Management Supported
Requirements Review Supported
Task Management Supported
Test Case Tracking Supported
User Level Management Supported
Version Control Supported

Quality Management Features

Audit Management Not Supported
Complaint Management Not Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Not Supported
Defect Tracking Not Supported
Document Control Supported
Equipment Management Not Supported
ISO Standards Management Not Supported
Maintenance Management Not Supported
Risk Management Supported
Supplier Quality Control Not Supported
Training Management Not Supported

Requirements Management Features

Automated Functional Sizing Not Supported
Automated Requirements QA Not Supported
Automated Test Generation Not Supported
Automated Use Case Modeling Not Supported
Change Management Supported
Collaboration Supported
History Tracking Supported
Prioritization Supported
Reporting Supported
Status Reporting Supported
Status Tracking Supported
Summary Reports Supported
Task Management Supported
To-Do List Supported
Traceability Supported
User Defined Attributes Supported

Risk Management Features

Alerts/Notifications Not Supported
Auditing Not Supported
Business Process Control Not Supported
Compliance Management Supported
Corrective Actions (CAPA) Not Supported
Dashboard Supported
Exceptions Management Not Supported
Internal Controls Management Supported
IT Risk Management Supported
Legal Risk Management Not Supported
Mobile Access Not Supported
Operational Risk Management Not Supported
Predictive Analytics Not Supported
Reputation Risk Management Not Supported
Response Management Not Supported
Risk Assessment Supported

Enterprise Architecture Features

Application Portfolio Management Not Supported
Architecture Governance Supported
Capability Mapping Not Supported
Diagramming Not Supported
Idea Management Not Supported
Modeling & Simulation Supported
Project Management Supported
Risk Assessment Not Supported
Transformation Roadmapping Not Supported
Version Control Supported

IT Project Management Features

Bug Tracking Supported
Issue Management Not Supported
Milestone Tracking Supported
Percent-Complete Tracking Supported
Portfolio Management Supported
Prioritization Supported
Product Roadmapping Supported
Requirements Management Supported
Resource Management Supported
Status Tracking Supported
Supports Agile Supported
Supports Scrum Supported
Task Management Supported
Testing / QA Management Supported
Time & Expense Tracking Supported

Test Management Features

Automation Integration Not Supported
Collaboration Tools Supported
Pass/Fail Results Tabulation Not Supported
Reporting / Analytics Supported
Requirements Management Supported
Test Scheduling Not Supported
Test Tracking Supported
Time/Budget Tracking Supported

Workflow Management Features

Access Controls/Permissions Supported
Approval Process Control Not Supported
Business Process Automation Not Supported
Calendar Management Not Supported
Compliance Tracking Supported
Configurable Workflow Supported
Customizable Dashboard Supported
Document Management Supported
Forms Management Supported
Graphical Workflow Editor Supported
Mobile Access Not Supported
No-Code Not Supported
Task Management Supported
Third Party Integrations Not Supported
Workflow Configuration Supported

Integrations

Jira Supported
Microsoft 365 Supported
Microsoft Excel Not Supported
Microsoft Project Not Supported
Microsoft Visio Not Supported
Microsoft Word Not Supported
Salesforce Supported

Integrations

Jira Supported
Microsoft 365 Not Supported
Microsoft Excel Supported
Microsoft Project Supported
Microsoft Visio Supported
Microsoft Word Supported
Salesforce Not Supported
Claim Orcanos and update features and information
Claim Orcanos and update features and information
Claim objectiF RPM and update features and information
Claim objectiF RPM and update features and information