Requirements Management Tool for Medical Device
Streamline Product Development, Ensure Compliance, and Eliminate Bottlenecks with Orcanos.
Why Choose Orcanos Requirements Management Tools?
Orcanos provides a unified repository for managing requirements, documents, and workflows. This centralized approach ensures your team has access to accurate, up-to-date information, improving collaboration and reducing the risk of errors or miscommunication.
Key Features for Medical Device Development
Central Repository
Store all requirements securely in one location for easy access and reliable data integrity.
Part 11 Compliance with Electronic Signatures
Meet FDA 21 CFR Part 11 requirements with secure electronic signatures for critical actions.
Import/Export Support
Effortlessly integrate over existing tools and from MS Word/Excel by importing or exporting requirements to and from MS Word/Excel.
Support for Multiple Requirement Types
Manage functional, design, and user needs requirements within a single system.
Validation and Verification
Ensure comprehensive traceability and compliance by linking requirements to tests using Orcanos Test Management Tool.
Full Audit Trail
Maintain a detailed history of all actions for enhanced transparency and compliance.
End-to-End Traceability
Orcanos provides unmatched traceability across all Design Control and Application Lifecycle Management (ALM) artifacts. Easily connect requirements to test cases, results, risk assessments, CAPAs, and customer complaints.
Benefits of Traceability with Orcanos
Meet FDA, ISO 13485, and IEC 62304 standards.
Link requirements to risks using FMEA methodologies for proactive management.
Automatically flag and track changes to assess their impact on associated work items.
Online Document Review for Better Collaboration
Streamlined Review Process
Collaborate efficiently with Orcanos’ online document review tool, allowing multiple users to review, edit, and approve documents simultaneously while maintaining full security and integrity.
Automated Document Generation
Generate comprehensive reports with Orcanos DocGen. Use customizable templates and embedded data to create regulatory-ready documents directly from your electronic records repository.
Baseline Management Made Simple
Managing baselines and versioning is critical for maintaining design control. Orcanos automates these processes, ensuring:
Integrated Risk Management
Link requirements to risks and streamline mitigation planning. Orcanos' integrated approach helps you manage risks proactively and ensures compliance with industry regulations.
Additional Features of Orcanos Requirements Management Tools
Combine Application Lifecycle Management (ALM) and Quality Management System (QMS) in one solution. Seamlessly manage requirements, risks, testing, CAPAs, and customer complaints.
Adapt workflows to align with your organizational processes for greater efficiency and compliance.
Automate compliance tracking for medical device standards, freeing your team to focus on innovation.
Enable real-time collaboration across cross-functional teams with shared access to tools and data.
Streamline your requirements management, eliminate inefficiencies, and achieve seamless industry compliance with Orcanos—your comprehensive solution for managing medical device requirements, risks, and quality.
How Orcanos Benefits Your Business
For Medical Device Developers:
For Quality Assurance Teams:
Why Compliance is Crucial in Medical Device Development
Regulatory bodies like the FDA and ISO demand stringent control over medical device design and manufacturing. Orcanos ensures your organization can:
Frequently Asked Questions (FAQs)
What is requirements management, and why is it important?
How does requirements management help with project success?
What tools are commonly used for managing requirements?
What is traceability in requirements management, and why does it matter?
What are the biggest challenges in managing requirements, and how can they be addressed?
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