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Automating Risk Management within the Engineering Lifecycle for Medical Devices

Hazard analysis and risk management are standard procedures that medical device companies must undertake as part of their compliance effort for FDA regulations and other standards. The challenge is that risks are typically managed manually and separately from control measures and other engineering lifecycle artifacts such as requirements and tests. Tracing risks, producing risk reports and validating risk mitigation becomes an arduous task that extends development cycles and delays time to market.

Attend this Webinar and learn how MKS Integrity automates the capture, management and tracing of hazards to risks and risk control measures. A solution demonstration will show how medical device organizations can automate risk management processes and connect them to development and verification processes. See how MKS Integrity provides:

• automated calculation of risk level and Risk Priority Number (RPN)
• hazard to test case traceability reports
• immediate and real-time risk coverage and other product readiness milestone metrics, and
• the traceability to easily generate complex traceability reports and configurable risk matrices that streamline the creation of the Design History File (DHF).

The result is a more accurate, reliable and efficient way of managing risk, and a significant reduction in effort for compliance.