Orcanos QMS Software: Elevate Quality Management in Medical Device Compliance

About Orcanos ALM and QMS

Orcanos QMS software stands out as a premier solution for organizations in the medical device industry seeking to enhance their quality management systems. The platform offers a comprehensive, cloud-based approach that not only meets but exceeds regulatory compliance standards, including ISO 13485 and 21 CFR Part 820.

One of the most impressive features of Orcanos QMS is its ability to centralize all quality processes, effectively eliminating the inefficiencies associated with paper-based systems. This transition to a digital framework allows for streamlined document control, risk management, and change management, ensuring that organizations can navigate the complexities of compliance with ease.

The integration of risk management into the QMS processes is particularly noteworthy. By adhering to ISO 14971 guidelines, Orcanos helps organizations mitigate potential hazards throughout the device lifecycle, enhancing overall product safety and reliability. Additionally, the platform's robust audit management and complaints handling systems prepare users for inspections and facilitate effective resolution of issues.

Orcanos also excels in customization, allowing users to tailor the software to their specific needs and standard operating procedures. This flexibility, combined with powerful analytics and reporting tools, empowers organizations to maintain oversight of their quality procedures and project statuses.

Orcanos QMS software is an invaluable asset for any medical device company aiming to achieve and maintain compliance while improving quality control processes. The platform's user-friendly interface, comprehensive features, and commitment to regulatory standards make it a top choice in the industry. Scheduling a demo is highly recommended to experience the full capabilities of this integrated solution.

Requirements Management Features

• Change Management
• Collaboration
• History Tracking
• Prioritization
• Reporting
• Status Reporting
• Status Tracking
• Summary Reports
• Task Management
• To-Do List
• Traceability
• User Defined Attributes

Application Lifecycle Management Features

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