Risk Management

Mitigate Risks, Safeguard Compliance

This platform automates and streamlines risk management processes to protect patients and ensure device compliance with ISO 14971:2019 and ISO 13485:2016 standards.

Comprehensive Risk Control Made Simple

• Prebuilt for ISO 14971:2019
• Out-of-the-box FMEA templates
• Cloud-based for real-time collaboration
• Seamless eQMS integration with other modules
• Startup-friendly, fast to deploy, and scalable

Clear Risk Evaluation for Informed Decisions

The Risk Matrix allows teams to quickly assess risk levels by evaluating probability against severity. It is designed for intuitive use and aligns with DFMEA best practices, helping guide effective risk control measures. Visual indicators help teams prioritize actions to enhance safety and compliance.

Systematic Tracking of Hazards and Failure Modes

This structured dashboard facilitates the documentation and assessment of potential hazards, failure modes, and associated harms. It tracks 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.

Effective Risk Management Processes

The module helps identify, assess, and control risks to ensure compliance and product safety throughout the device lifecycle. It allows for the definition and management of probability, severity, and detectability, modeling harms and hazards, and configuring risk controls across various device types and geographies.

With built-in support for risk acceptability ranges and out-of-the-box FMEA templates, the system empowers teams to streamline assessments and stay aligned with ISO standards.

Frequently Asked Questions

The module aligns with ISO 14971:2019, ensuring that device risk assessment, control, and mitigation processes meet industry and regulatory expectations. It is web-based, enabling seamless collaboration across teams, including design partners and consultants, ensuring all stakeholders have access to the latest information.

The module offers out-of-the-box templates for various risk assessments, including user (uFMEA), design (dFMEA), and process (pFMEA) assessments. It can also be configured to manage specialized risk assessments unique to specific devices or processes, allowing for comprehensive risk management tailored to specific needs.

Tools are provided to identify hazards, estimate potential failure modes, and assess the severity, probability, and detectability of risks. Users can define and implement risk control measures, document their effectiveness, and continuously monitor residual risks, ensuring comprehensive management and mitigation throughout the device lifecycle.