April 24, 2024
International Influences on a Lifecycle Risk Management System
It is vitally important to understand the medical device regulatory expectations and business optimization benefits of integrating a lifecycle Risk Management System (RMS) and Quality Management System (QMS). Lately there are many global and non-medical sector influences on the RMS standards and requirements. Some of those influences will be discussed to ensure attendees are aware of the multifaceted issues being addressed within the hot topic of addressing “risk.” Additionally, practical experience will be shared on some hot sub-topics related to RMS such as Usability Testing and international utilization of IEC 62366, as well as shared experiences on required Post Market Surveillance reports utilizing risk data.
Kim Trautman, Managing Director and VP, MedIcept, Inc.
Aaron Dunbar, Vice President of Quality Systems & Post Market, Boston Scientific
Matt Graf, Quality Assurance & Global Quality Systems, Cook Medical
Melissa Torres, Associate Director for International Affairs, Center for Devices and Radiological Health (CDRH), FDA