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.
Learning Objectives:
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
