Global Regulatory Transformation for Medical Devices and Diagnostics: Industry, FDA, and Notified Body Perspectives

In response to the recent MDR deadline, component delays, and partial implementations, medical device and diagnostics companies are transforming the way they manage regulatory information and operations to meet new requirements. Not only are they contending with a dynamic regulatory environment, but they’re also facing the reorganization at CDRH. All of these modifications have the public health front of mind, but they require regulatory operations to adopt a new way of thinking to accommodate for these and future changes. Industry and regulators are demanding more from cross-functional teams as they must increase collaboration, pull insights from real-time data, and drive efficiency. The focus for these organizations is not just on compliance, but instead on implementing changes that will be sustainable in the near and long term to protect and promote public health while controlling costs.

In this session, regulatory and industry experts will deliver a series of brief presentations followed by a panel discussion to explore how they are preparing for this kind of global regulatory transformation.