Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 1 Rating

Total
ease
features
design
support

Description

Orcanos is an integrated MedTech software platform built to help medical device companies manage quality, compliance, product development, and regulatory documentation from one connected workspace. It combines electronic quality management, application lifecycle management, design controls, document control, risk management, traceability, and audit readiness. The platform is designed to bridge the gap between R&D and Quality teams by connecting user needs, requirements, hazards, mitigations, tests, validations, complaints, and quality processes. Orcanos supports regulated frameworks and standards such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Its eQMS capabilities include document workflows, PDF publishing, revision control, electronic signatures, training automation, audit trails, CAPA support, and quality process management. ALM and design control features help teams maintain a live digital thread across development artifacts, risk files, verification activities, and design history documentation. Orcanos also offers customizable no-code workflows, configurable fields, granular permissions, and migration support for teams moving from spreadsheets or legacy tools. Its AI-powered assistant, Ask Paul, is positioned to help users navigate operations and improve efficiency. By unifying quality and development data, Orcanos helps medical device organizations stay audit-ready while reducing manual documentation work.

Description

Enterprise software to improve business agility. objectiF RPM features include portfolio, requirements, test and risk management. UML/SysML diagrams allow you to visualize requirements, goals, and processes. You can also manage backlogs at different levels (from business use case, user story), plan taskmanagement with Kanban boards and run queries across multiple projects. This allows you to collaborate with distributed teams using one source of information. The software can be customized to meet your corporate needs. It is flexible, extensible, and integrable. It provides templates for agile and mixed project management, digitization programs, and projects following Scaled Agile Framework®, SAFe.

API Access

Has API No 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Jira Yes 
Microsoft 365 Yes 
Microsoft Excel No 
Microsoft Project No 
Microsoft Visio No 
Microsoft Word No 
Salesforce Yes 

Integrations

Jira Yes 
Microsoft 365 No 
Microsoft Excel Yes 
Microsoft Project Yes 
Microsoft Visio Yes 
Microsoft Word Yes 
Salesforce No 

Pricing Details

No price information available.
Free Trial Yes 
Free Version Yes 

Pricing Details

129 €/month/concurrent user
Free Trial Yes 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App Yes 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based No 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Orcanos

Founded

2004

Country

Israel

Website

www.orcanos.com

Vendor Details

Company Name

microTOOL

Founded

1984

Country

Germany

Website

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

Product Features

Application Lifecycle Management

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

Audit

Alerts / Notifications No 
Audit Planning No 
Compliance Management No 
Dashboard No 
Exceptions Management No 
Forms Management No 
Issue Management No 
Mobile Access No 
Multi-Year Planning No 
Risk Assessment No 
Workflow Management No 

CAPA

Audit Management No 
CAPA Planning No 
Change Management No 
Complaint Management No 
Incident Management No 
Nonconformance Tracking No 
Quality Control No 
Risk Management No 
Root Cause Analysis No 
Training Management No 

Compliance

Archiving & Retention No 
Artificial Intelligence (AI) No 
Audit Management No 
Compliance Tracking No 
Controls Testing No 
Environmental Compliance No 
FDA Compliance No 
HIPAA Compliance No 
ISO Compliance No 
Incident Management No 
OSHA Compliance No 
Risk Management No 
Sarbanes-Oxley Compliance No 
Surveys & Feedback No 
Version Control No 
Workflow / Process Automation No 

Document Control

Archiving & Retention No 
Automated Routing No 
Change Management No 
Compliance Management No 
Electronic Signature No 
Escalation Management No 
Periodic Review No 
Version Control No 

Quality Management

Audit Management No 
Complaint Management No 
Compliance Management No 
Corrective and Preventive Actions (CAPA) No 
Defect Tracking No 
Document Control No 
Equipment Management No 
ISO Standards Management No 
Maintenance Management No 
Risk Management No 
Supplier Quality Control No 
Training Management No 

Requirements Management

Automated Functional Sizing No 
Automated Requirements QA No 
Automated Test Generation No 
Automated Use Case Modeling No 
Change Management Yes 
Collaboration Yes 
History Tracking Yes 
Prioritization Yes 
Reporting Yes 
Status Reporting Yes 
Status Tracking Yes 
Summary Reports Yes 
Task Management Yes 
To-Do List Yes 
Traceability Yes 
User Defined Attributes Yes 

Risk Management

Alerts/Notifications No 
Auditing No 
Business Process Control No 
Compliance Management No 
Corrective Actions (CAPA) No 
Dashboard No 
Exceptions Management No 
IT Risk Management No 
Internal Controls Management No 
Legal Risk Management No 
Mobile Access No 
Operational Risk Management No 
Predictive Analytics No 
Reputation Risk Management No 
Response Management No 
Risk Assessment No 

Product Features

Application Lifecycle Management

Administrator Level Control No 
Defect Tracking Yes 
Iteration Planning Yes 
Project Management Yes 
Release Management Yes 
Requirements Review Yes 
Task Management Yes 
Test Case Tracking Yes 
User Level Management Yes 
Version Control Yes 

Enterprise Architecture

Application Portfolio Management No 
Architecture Governance Yes 
Capability Mapping No 
Diagramming No 
Idea Management No 
Modeling & Simulation Yes 
Project Management Yes 
Risk Assessment No 
Transformation Roadmapping No 
Version Control Yes 

IT Project Management

Bug Tracking Yes 
Issue Management No 
Milestone Tracking Yes 
Percent-Complete Tracking Yes 
Portfolio Management Yes 
Prioritization Yes 
Product Roadmapping Yes 
Requirements Management Yes 
Resource Management Yes 
Status Tracking Yes 
Supports Agile Yes 
Supports Scrum Yes 
Task Management Yes 
Testing / QA Management Yes 
Time & Expense Tracking Yes 

Quality Management

Audit Management No 
Complaint Management No 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) No 
Defect Tracking No 
Document Control Yes 
Equipment Management No 
ISO Standards Management No 
Maintenance Management No 
Risk Management Yes 
Supplier Quality Control No 
Training Management No 

Requirements Management

Automated Functional Sizing No 
Automated Requirements QA No 
Automated Test Generation No 
Automated Use Case Modeling No 
Change Management Yes 
Collaboration Yes 
History Tracking Yes 
Prioritization Yes 
Reporting Yes 
Status Reporting Yes 
Status Tracking Yes 
Summary Reports Yes 
Task Management Yes 
To-Do List Yes 
Traceability Yes 
User Defined Attributes Yes 

Risk Management

Alerts/Notifications No 
Auditing No 
Business Process Control No 
Compliance Management Yes 
Corrective Actions (CAPA) No 
Dashboard Yes 
Exceptions Management No 
IT Risk Management Yes 
Internal Controls Management Yes 
Legal Risk Management No 
Mobile Access No 
Operational Risk Management No 
Predictive Analytics No 
Reputation Risk Management No 
Response Management No 
Risk Assessment Yes 

Test Management

Automation Integration No 
Collaboration Tools Yes 
Pass/Fail Results Tabulation No 
Reporting / Analytics Yes 
Requirements Management Yes 
Test Scheduling No 
Test Tracking Yes 
Time/Budget Tracking Yes 

Workflow Management

Access Controls/Permissions Yes 
Approval Process Control No 
Business Process Automation No 
Calendar Management No 
Compliance Tracking Yes 
Configurable Workflow Yes 
Customizable Dashboard Yes 
Document Management Yes 
Forms Management Yes 
Graphical Workflow Editor Yes 
Mobile Access No 
No-Code No 
Task Management Yes 
Third Party Integrations No 
Workflow Configuration Yes 

Alternatives

Alternatives

Modern Requirements4DevOps Reviews

Modern Requirements4DevOps

Modern Requirements
ReqSuite® RM Reviews

ReqSuite® RM

OSSENO Software GmbH
Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences
Modern Requirements4DevOps Reviews

Modern Requirements4DevOps

Modern Requirements
aligned elements Reviews

aligned elements

Aligned AG
objectiF RM Reviews

objectiF RM

microTOOL