Description: With the implementation of ISO 13485:2016, ISO 14971:2019 and the EU MDR/IVDR, Risk Management has become a central focus for medical device safety and for a data-driven risk-based approach to Quality Management Systems. Risk Management is applicable throughout the product's lifecycle and should integrate with the Clinical, Design, Manufacturing, and Post-Market Surveillance processes as well as CAPA and the Quality Management System as a whole. This session will discuss the central focus of Risk Management. It will provide one how-to example for Risk Management integration, and it will discuss court cases in the EU and USA where Risk Management has become the central focus in liability suits.
Understand the role of the Risk Management File and how Risk Management is central to all processes
Describe a method for planning and implementing a sustainable, systematic approach to Risk Management that integrates all elements of the product's lifecycle
Understand the legal implications of Risk Management in product safety and Manufacturer’s liability