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QMS Software for Medical Devices

QMS Software for Medical Devices


In the dynamic landscape of medical device manufacturing, ensuring regulatory compliance and maintaining the highest standards of quality is paramount. This is where Quality Management Systems (QMS) play a pivotal role. Among the myriad of QMS software options available, Orcanos stands out as a comprehensive solution tailored specifically for the medical device industry. Let's delve into why Orcanos is considered one of the best QMS software options for medical devices.

Streamlined Compliance with Regulatory Standards

Orcanos QMS software is designed to facilitate compliance with a range of regulatory standards, including ISO 13485, 21 CFR Part 820, and GMP (Good Manufacturing Practice). By providing a centralized platform for all quality processes, Orcanos eliminates the inefficiencies associated with paper-based systems and ensures adherence to strict FDA regulations and established ISO quality standards.

Key Features for Enhanced Quality Management

Orcanos offers a suite of features that address various aspects of quality management:

1. Document Control: Automate compliance processes and streamline document routing and sign-off procedures. Orcanos' Change Control feature enables the seamless release of new document revisions.

2. Risk Management: Integrated risk management capabilities help organizations comply with ISO 14971 and mitigate risks throughout the device lifecycle.

3. Change Management (ECO): Automate change management workflows and release batches of documents efficiently.

4. Complaints Handling: Orcanos provides a comprehensive system for managing complaints, guiding users from investigation to resolution.

5. CAPA Management: Ensure compliance and enhance quality control processes through effective Corrective and Preventive Action (CAPA) management.

6. Audit Management: Prepare for audits and inspections with confidence using Orcanos' audit management tools.

7. Nonconformance Management: Simplify the recording and tracking of non-conformance issues from identification to resolution.

8. Training Management: Streamline employee training processes with Orcanos' training management software.

9. Supplier Qualification: Consolidate supplier-related documents, schedules, scorecards, and risk assessments within the QMS for improved supplier management.

Standout Features of Orcanos

1. ALM and QMS Integration: Orcanos seamlessly integrates Design Control (ALM) with the Quality Management System, establishing a centralized repository for all relevant data.

2. Document Generator: Effortlessly generate submission-ready documents conforming to company templates, saving time and ensuring consistency.

3. Integrated Risk Management:** By integrating risk management into development processes and quality events, Orcanos helps prevent potential hazards and failures while adhering to ISO 14971 guidelines.

4. 21 CFR Part 11 Compliance: Orcanos supports electronic records and signatures, ensuring compliance with 21 CFR Part 11/Annex 11 requirements.

5. Dashboards and Analytics: Keep track of projects and quality procedures with detailed reports and charts through customized dashboards.

6. Easy Customization: Orcanos offers powerful customization tools to tailor quality forms, e-sign processes, status flows, rules, and permissions to specific organizational needs and Standard Operating Procedures.


In the competitive landscape of medical device manufacturing, choosing the right QMS software is crucial for ensuring regulatory compliance, enhancing product quality, and maintaining operational efficiency. Orcanos emerges as a top contender, offering a robust suite of features tailored specifically for the medical device industry. From document control to supplier qualification and beyond, Orcanos empowers organizations to navigate the complexities of quality management with ease and confidence.

Schedule a demo today to experience firsthand the power and effectiveness of Orcanos QMS software in elevating your quality management processes. With Orcanos by your side, you can navigate regulatory requirements seamlessly while focusing on what matters most: delivering safe and effective medical devices to patients worldwide.

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