Requirements Management Tool for Medical Device

Streamline Product Development, Enhance Compliance, and Reduce Bottlenecks with Orcanos

Why Choose Orcanos Requirements Management Tools?

Centralized Platform for Complete Control
Orcanos provides a single repository for managing requirements, documents, and associated workflows. This centralization ensures your team can access accurate and up-to-date information, improving collaboration and reducing the risk of miscommunication.

Key Features for Medical Device Development

Central Repository

Keep all requirements in one secure location, ensuring data integrity and easy accessibility.

Part 11 Compliance with Electronic Signatures

Simplify compliance with FDA 21 CFR Part 11 through secure electronic signatures for all critical actions.

Import/Export Support

Effortlessly integrate with existing tools by importing/exporting requirements to and from MS Word/Excel.

Support for Multiple Requirement Types

Manage various types of requirements, including functional, design, and user needs, in one system.

Validation and Verification

Ensure that requirements are validated and verified using the Orcanos Test Management Tool, providing traceability to testing.

Full Audit Trail

Ensure that requirements are validated and verified using the Orcanos Test Management Tool, providing traceability to testing.

End-to-End Traceability

Orcanos offers unmatched traceability across all Design Control (ALM: Application Lifecycle Management) artifacts. Seamlessly connect requirements to test cases, test results, risk assessments, CAPAs, and customer complaints.

Benefits of Traceability with Orcanos

Regulatory Compliance
‍Ensure adherence to FDA, ISO 13485, and IEC 62304 requirements.

Risk Mitigation
‍Link requirements directly to risks using FMEA methodologies for proactive management.

Efficient Change Management
Automatically flag and track changes to identify their impact on associated work items.

Online Document Review for Better Collaboration

Streamlined Review Process
Collaborate effortlessly with your team using Orcanos’ online document review tool. Multiple users can access, edit, and approve documents simultaneously while maintaining full document integrity and security.

Document Generation with MS Word

Orcanos DocGen allows you to generate comprehensive documents from your electronic records repository. Build reports using customized templates and embedded data to meet regulatory documentation needs.

Baseline Management

Managing baselines and versioning is critical in maintaining design control. Orcanos automates these processes, ensuring:

Real-time visibility into changes.

Accurate comparisons between iterations.

Simplified approvals for regulatory audits.

Traceability to Risk

Link requirements to identify risks to streamline mitigation planning and documentation. This integrated approach allows for proactive risk management and compliance with regulatory standards.

Three overlapping circles of Standards, ALM and QMS with Risks in the middle.

Additional Features of Orcanos Requirements Management Tools

Integrated ALM and QMS
‍Combine Application Lifecycle Management (ALM) and Quality Management System (QMS) capabilities in a single tool. Manage requirements, testing, risks, CAPAs, and customer complaints seamlessly.

Customizable Workflows
Tailor workflows to fit your organizational processes, ensuring maximum efficiency and adherence to industry standards.

Compliance Made Easy
‍Orcanos automates compliance tracking for medical device standards, reducing the burden on your team and allowing you to focus on innovation.

Collaborative Features
‍Enable cross-functional collaboration by providing teams with real-time access to data and tools they need.

Simplify your requirements management, eliminate bottlenecks, and ensure industry compliance with Orcanos - your all-in-one solution for managing medical device requirements, risks, and quality.

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How Orcanos Benefits Your Business

For Medical Device Developers:

Simplified regulatory audits with automated traceability and document generation.

Improved collaboration across dispersed teams.

For Quality Assurance Teams:

Enhanced visibility into the lifecycle of each requirement.

Improved accuracy in validation and verification.

Comprehensive audit trails for all actions.

Adaptive Compliance sixtagon in the middle with six circles around with the six points that are covered in the text on the right.

Why Compliance is Crucial in Medical Device Development

Regulatory bodies like the FDA and ISO demand stringent control over the design and manufacturing of medical devices. Orcanos Requirements Management Tools are built to help you

Avoid costly recalls by ensuring design control.

Demonstrate compliance with full traceability and documentation.

Enhance patient safety through rigorous risk management.

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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