Streamline your product risk management with a compliant, policy-driven workflow aligned with ISO 14971 standards. Simplify audits and inspections by centralizing all risk-related data in one location, reducing complexity and ensuring easy access to critical information.

Build a Risk Management System that minimizes product risks and maintains a controlled, iterative risk management process.

Consolidate all your product risk information into one centralized location, streamlining risk assessments and simplifying the maintenance of product risk files, resulting in shorter cycle times.

Effectively define policies and thresholds to identify, document, and mitigate product risks with tools designed for efficient and thorough risk management.

Follow a built-in, streamlined workflow that ensures consistent execution of tasks, so the right steps are taken at the right time to manage product risk.

Avoid chasing down data by leveraging seamless integration that provides the insights needed to manage product risks and improve medical device quality and patient safety.

Easily access comprehensive product risk files through the Quality Intelligence dashboard, using powerful reporting capabilities to reduce audit findings and ensure compliance.