The 3rd Edition of the medical device risk management standard ISO 14971:2019 and its companion guidance document ISO TR 24971:2019 include several new distinctions that manufacturers must understand and follow, such as placing an emphasis on the “benefit” aspect of the benefit-risk ratio, among others.
Attendees will learn about the specific changes that differ from previous versions and the impact of these changes on existing processes, so manufacturers understand what they must do to follow the new requirements of ISO 14971:2019.
We’ll extrapolate on this topic of risk by offering relevant key metrics gathered from our 2020 industry benchmark report of over 500 medical device professionals around the globe on the topic of ISO 14971 and risk management practices.
We’ll take a close look at applicable findings that were uncovered, such as, more than half of medical device companies say they use legacy systems to manage risk. Additionally, 1 in 3 device makers say product-level risk management is minimally or not at all integrated with post-market quality processes.
Attendees will gain valuable insight into these current market trends in medical device risk management, while also receiving our top recommendations for tools and solutions they can use to integrate risk into their entire product lifecycle and achieve full closed-loop traceability for all processes within their quality system.
Interpret and follow risk management best practices outlined in the latest version of the 14971 standard.
Integrate risk management best practices with design and post-market quality activities over the course of their device lifecycle.
Use risk management as a tool, rather than a checkbox activity, by following recommended best practices from ISO 14971:2019.