SmartSolve Risk Management

Risk Management Software - Reduce Product Risk to Improve Patient Safety

Audit Management Software System

Reduce the challenges of audits and inspections by consolidating all your risk information in a single location. SmartSolve® Risk Management software enables medical device manufacturers to streamline the product risk management process with a compliant, policy-driven workflow, based on ISO 14971:2019. Our Risk Management system helps reduce product risk and demonstrates that you control an iterative risk management process with tools to:

  • Eliminate risk-related data silos.
    Consolidate all your product risk content, such as the risk plan, analysis, evaluation, controls, residual risk and periodic reviews, into a single location. By maintaining all risk-related documentation in one system, you can reduce costly and time-consuming errors that could arise if your data is siloed. Risk Management’s streamlined approach will shorten cycle times for risk assessments and simplify the maintenance of your Product Risk Files.
  • Control, identify and mitigate risk.
    Effectively and efficiently define risk policies and thresholds to document and assess product risk. Through your product risk view you can easily see changes to product, process or defect history enabling you to quickly identify and mitigate potential risk.
  • Perform the right tasks at the right time.
    Follow a built-in, streamlined workflow that ensures a consistent process to allow the right people to focus on the most significant risk assessments at the right time. Through this policy-driven workflow designed for ISO 14971:2019 compliance, you can efficiently work through product risk assessments while shortening cycle times and reducing the burden of audits and inspections.
  • Improve quality with closed-loop integration.
    Drive continuous improvement and increase the quality system’s overall effectiveness by taking advantage of SmartSolve’s ecosystem of quality compliance solutions. Rather than chasing data to manage your product risk, quality records from internal and external Nonconformance, CAPA, Complaint and Design activities are automatically pulled into periodic product risk reviews. SmartSolve’s integrated framework for managing product risk equips you with the data needed to improve your medical device quality and patient safety.
  • Reduce audit findings.
    Lighten the demands of completing inspections and reduce your audit findings by following SmartSolve Risk Management’s ISO 14971-based, policy-driven workflow. Through the solution’s Quality Intelligence dashboard and reporting capabilities, you can easily access each of your Product Risk Files containing all product risk information necessary to fulfill your regulatory requirements.


Risk Management is an integrated part of our SmartSolve quality management software.


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