WATCH NOW: Risk Management and Design Controls for Medical Devices

January 31, 2019; 9am CST

In fulfilling their regulatory obligations, manufacturers face many challenges, including establishing and implementing processes for design, production, purchasing, competency, validation, CAPA, and many others. Among these, the design and development process is key to successfully ensuring patient safety.  

Understanding user needs is a foundational step in the design and development process as well as any risk management effort. Once identified, user needs become design input requirements, which are translated into design output requirements that can take many forms, including specific designs, construction methods and quality management system processes.  

As required by ISO 14971, line-of-sight traceability between the identified user needs (safety), design input requirements, and design output requirements is necessary. Once product realization occurs, the risk management process can monitor the effectiveness of the actions taken and establish the necessary feedback loop to ensure ongoing lifecycle safety of the device. 

In this one-hour webinar, Mark Leimbeck, PE will describe the key steps in this process, and illustrate the critical linkage between risk management and the quality management system necessary to provide and preserve patient safety.



Mark Leimbeck is a Program Manager for UL Health Sciences with more than 30 years of experience working in roles including Operations Manager, Program Manager, and Principal Engineer. He is responsible for developing new services, training, and representing UL on International standards and other technical development committees. Mark holds a bachelor’s degree in Electrical Engineering Technology from Southern Illinois University and a master’s degree in Business Administration from the University of Chicago.