Risk Management

SmartSolve® Risk Management enables medical device manufacturers to streamline their product risk management process with a compliant, policy-driven workflow, based on ISO 14971, that reduces the challenges of audits and inspections by consolidating all risk information in a single location.
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Reduce product risk to improve patient safety.

SmartSolve® Risk Management helps reduce product risk and demonstrates that you control an iterative risk management process with tools to:

  • Eliminate risk-related data silos by consolidating all your product risk content into a single location. This results in shortened cycle times for risk assessments and simplified maintenance of your Product Risk Files.
  • Control, identify and mitigate risk with capabilities to effectively and efficiently define policies and thresholds to document and assess product risk.
  • Perform the right tasks at the right time by following a built-in, streamlined workflow that ensures a consistent process for working through product risk.
  • Improve quality with closed-loop integration that eliminates the need to chase data to manage your product risk and equips you with the data needed to improve your medical device quality and patient safety.
  • Reduce audit findings by using Risk Management’s Quality Intelligence dashboard and reporting capabilities to easily access each of your Product Risk Files containing all your product risk details.

Learn how to manage and monitor your organization’s Risk Management process in compliance with regulatory requirements.

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