Risk Management
Mitigate Risks,
Safeguard Compliance
Automate and streamline risk management to protect patients and support device compliance with ISO 14971:2019 and ISO 13485:2016.
Comprehensive Risk Control
Made Simple
Comprehensive Risk Control
Made Simple
Clear risk evaluation for informed decisions
This Risk Matrix helps teams quickly assess risk levels by evaluating probability against severity. Designed for intuitive use, it aligns with DFMEA best practices, guiding effective risk control measures. With clear visual indicators, teams can prioritize actions for improved safety and compliance.
Systematic tracking of hazards and failure modes
Easily document and assess potential hazards, failure modes, and associated harms with this structured dashboard. Track each failure’s severity, probability, and required control measures, ensuring compliance and prioritization of critical risks. This organized view supports effective decision-making and continuous risk mitigation throughout the product lifecycle.
Looking for an effective way to manage your risk processes?
Grand Avenue Software’s Risk Management module helps you identify, assess, and control risks to ensure compliance and product safety throughout the device lifecycle. Define and manage probability, severity, and detectability; model harms and hazards; and configure your risk controls across a wide range of device types and geographies.
With built-in support for risk acceptability ranges and out-of-the-box FMEA templates, our system empowers teams to streamline assessments and stay aligned with ISO 14971:2019 and ISO 13485:2016.
Request a Demo today to see how we can help streamline your risk management process.
Frequently Asked Questions
Our Risk Management module is aligned with ISO 14971:2019, the internationally recognized standard for applying risk management to medical devices. This ensures that your device risk assessment, control, and mitigation processes meet industry and regulatory expectations.
The module is web-based, enabling seamless collaboration across your team, including design partners and consultants. This setup ensures that every stakeholder has access to the latest information and can contribute effectively to risk management activities.
Grand Avenue’s Risk Management module offers out-of-the-box templates for various types of risk assessments, including user (uFMEA), design (dFMEA), and process (pFMEA) assessments. Additionally, the module can be configured to manage other specialized risk assessments unique to your device or process, allowing for comprehensive risk management tailored to your needs.
The module provides tools to identify hazards, estimate potential failure modes, and assess the severity, probability, and detectability of risks. You can define and implement risk control measures, document their effectiveness, and continuously monitor residual risks, ensuring that all risks are comprehensively managed and mitigated throughout the device lifecycle.