Master Change Control with Orcanos

Change is inevitable, Orcanos ensures it’s seamless.

Streamline your change management and engineering processes with a comprehensive system that tracks, controls, and automates workflows across the product lifecycle.

Why Choose Orcanos for Change Control?

Change Control Challenges

Managing change manually in paper-based systems increases risks, delays, and inefficiencies.

Without a centralized solution, teams struggle to maintain compliance and collaboration.

The Orcanos Solution

‍ Orcanos Change Control software provide a robust, integrated approach to manage your quality and engineering workflows. Gain complete visibility and control with features designed to optimize processes and ensure compliance.

Comprehensive Change Management Features

Integrated Change Control System

Manage changes across documents, design controls, and quality records in a single platform.

Link changes to quality events like audits or complaints to demonstrate continuous improvement.

Automate notifications, approvals, and training workflows to ensure alignment across your team.

Benefits of Orcanos Engineering Change Order

Efficiency: Simplify your workflows, reducing time and effort spent on manual processes.

Transparency: Track every stage of change with real-time updates and comprehensive audit trails.

Compliance: Stay ready for audits with automated documentation and electronic approvals.

Collaboration: Bring stakeholders together with centralized, user-friendly tools.

Control the Change

Use the ECO to add, modify, or obsolete documents with precision.

Rely on Orcanos’ user-friendly platform to manage, track, and control changes effortlessly from start to completion.

Why Orcanos

Key Features

ECO Tracking: Monitor every step of the change process.

Electronic Signature Support: Ensure secure and compliant approvals.

Custom Workflows: Adapt Orcanos to fit your exact business requirements.

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Proven Results Trusted by regulated industries for its ability to streamline quality management.

Flexible enough to handle the unique demands of medical device companies, pharmaceuticals, and more.

Revolutionize your approach to change control and ECO with Orcanos' integrated solutions.

Frequently Asked Questions (FAQs)

What is FMEA in medical device risk management?

FMEA (Failure Mode and Effects Analysis) is a systematic approach used in medical device risk management to identify potential failures in a product, process, or design. By analyzing failure modes, their causes, and effects, manufacturers can proactively mitigate risks, ensuring product safety and compliance with standards like ISO 14971.

How does ISO 14971 apply to medical devices?

ISO 14971 is the international standard for risk management in medical device manufacturing. It requires manufacturers to identify hazards, evaluate associated risks, and implement controls to reduce those risks. Compliance ensures the safety and effectiveness of medical devices while meeting regulatory requirements worldwide.

What are the key differences between PFMEA, DFMEA, and UFMEA?

PFMEA (Process FMEA): Focuses on identifying risks in manufacturing and production processes.

DFMEA (Design FMEA): Analyzes risks in the product's design phase, ensuring reliability and functionality.

UFMEA (Use FMEA): Examines risks associated with how end-users interact with the device, focusing on user error and usability issues.

Why is risk management important for medical device manufacturers?

Risk management is crucial in medical device manufacturing to:

• Protect patient safety by mitigating hazards.
• Ensure compliance with regulations like ISO 14971 and FDA guidelines.
• Enhance product reliability and marketability.
• Prevent costly recalls and legal liabilities.

By integrating risk management into every stage of development, manufacturers can deliver safer, more effective devices.

How does Orcanos Risk Management Software support ISO 14971 compliance?

Orcanos simplifies ISO 14971 compliance by automating risk calculations, generating risk management documentation (RMF), and integrating design and quality management modules. It offers tools for FMEA analysis, real-time risk tracking, and customizable workflows to streamline processes and maintain traceability, reducing the effort required for compliance.