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What is agosense.fidelia?
Effective management of requirements is essential for the development of complex systems. In industries like automotive, rail transport, and medical technology, it is common for manufacturers and suppliers to work hand in hand to define these requirements. To enable this cooperation, a centralized database is essential. Since each partner utilizes distinct tools within their own secure environments, establishing a standardized format for sharing requirement data is crucial. Each organization has the autonomy to select the requirements management tool that best fits its operational needs. Tools that support ReqIF, such as agosense.fidelia, facilitate smooth data exchanges between companies without losing any critical information, thereby promoting effective collaboration throughout the development lifecycle. As a result, partners are able to comment on, refine, or alter an originally created document in an organized manner, ensuring that all modifications are meticulously documented and preserved. This systematic method not only improves communication but also significantly boosts the overall productivity of the development process. Moreover, it fosters a culture of transparency and shared understanding among all stakeholders involved.
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.
Integrations Supported
API Availability
API Availability
Pricing Information
Pricing not provided
Pricing Information
Pricing not provided
Free Version
Free Trial Offered?
Supported Platforms
SaaS
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
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
agosense
Date Founded
2009
Company Location
Germany
Company Website
www.agosense.com
Company Facts
Organization Name
Orcanos
Date Founded
2004
Company Location
Israel
Company Website
www.orcanos.com
Categories and Features
Requirements Management
Collaboration
History Tracking
Prioritization
Status Reporting
Summary Reports
To-Do List
Traceability
User Defined Attributes
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
Medical Quality Management Systems
Not specified
Quality Management
Not specified
Regulatory Change 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