Risk Management
Control Risks, Safeguard Compliance
Streamline and manage risk management to protect patients and support device compliance.
Comprehensive Risk Control Made Simple
Grand Avenue’s Risk Management module helps you manage your risk management file (RMF) by linking documents, storing your harms list, and utilizing your defined risk matrix to assess risks and implement effective controls all in one place. Designed for medical device innovators, this web-based tool ensures ISO 14971:2019 compliance while enhancing team collaboration.
clear risk evaluation for informed decisions
The Risk Matrix helps teams quickly assess risk levels by evaluating probability against severity. Designed for intuitive use, it aligns with risk analysis best practices, guiding effective risk control measures. With clear visual indicators, teams can prioritize actions for improved product safety and efficacy.
Systematic tracking of
hazards and failure modes
Easily describe and assess potential hazards, failure modes and link them to your associated harms. Utilize your defined risk matrix to automatically output your severity, probability and risk priority number (RPN). This organized view supports text search, sorting by column, and tracks changes for each line with the Status column. With the ability to document and link risk control measures, this module supports 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.
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.
Risk Management
from Grand Avenue
Out-of-the-box Functionality