Medical Device Risk Management Software
Orcanos Risk Management Software empowers medical device manufacturers to streamline risk management processes, ensuring compliance, efficiency, and safety.
Key Features at a Glance
Automatically calculate risk levels based on your SOP
Connect Design Control to enable comprehensive risk mitigation.
Gain insights with built-in dashboards to track Risks without mitigation, Failed risk verifications, and more.
ISO 14971 Compliance
Fully comply with ISO 14971:2019 standard, ensuring a proactive approach to medical device risk management. Simplify workflows, mitigate hazards, and reduce failure risks with confidence.
Take your regulatory compliance to the next level with Orcanos. Book a demo today and experience the power of our integrated solutions firsthand!
Why Choose Orcanos Risk Management?
Risk Automation
Effortlessly automate risk management tasks. Configure risk levels, probabilities, and calculations tailored to your SOP.
FMEA Support
Streamline Failure Mode and Effects Analysis (FMEA) by supporting PFMEA, DFMEA, and UFMEA types with customizable methodologies.
Customizable Workflows
Define electronic risk forms, set mandatory rules and access controls, and establish workflows for seamless collaboration and approval.
Cloud-Based Access
Access Orcanos Risk Management from anywhere. Stay connected with a secure, cloud-based compliance hub for your entire organization.
Powerful Reporting Tools
Monitor risks with dashboards and analytical reports. Automatically generate Risk Management File documents with traceability to eliminate human error and upload them to Orcanos' e-DMS for approval and e-signature.
Stay Ahead with Alerts and Risk Tracking
Automatically notify stakeholders about compliance anomalies.
Meet global standards effortlessly with built-in compliance tools.
Gain insights with built-in dashboards to track Risks without mitigation, Failed risk verifications, and more.
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.
Each type serves a specific stage of product lifecycle risk analysis, and using all ensures comprehensive risk management.
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.
