This is the resourceWebinar Recording
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 Integrity, a PTC product, (formerly 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. In addition, see how MKS provides the traceability to easily generate complex traceability reports which can be used to streamline the creation of the Device Master Record (DMR) and 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.
Originally Broadcast on June 29th, 2011
Presented by: John Hennessy Customer Solutions Director & Steve Mostello, Customer Solutions Engineer both with MKS Inc, a PTC Company
For more information on MKS Solutions for Medical Devices, click here or visit http://www.mks.com/solutions/by-industry/medical-devices.