Grand Avenue Software’s Risk Management module is built to support ISO 14971:2019, the internationally recognized standard for applying risk management to medical devices. The module includes out-of-the-box FMEA templates for user (uFMEA), design (dFMEA), and process (pFMEA) assessments, a built-in risk matrix for evaluating probability and severity, and tools for defining and tracking risk control…
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.
Grand Avenue Software’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 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.
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.