Description: Digital Health solutions represent the future of the healthcare industry. Despite the fact that several manufacturers are placing innovative devices on the market based on Artificial Intelligence and Machine Learning algorithms, technical files tend to differ dramatically between one and another. In this Session, we will provide an overview of the most common problems encountered by manufactuers during the registration process of digital health products in Europe. Our speakers will present both the point of view of Notified Bodies and the most common tactics used by manufacturers to address the regulatory requirements of the Medical Device Regulation, especially in the clinical domain.
Learning Objectives:
list the 3 most common mistakes in building submissions of Digital Health projects
define an effective mitigation strategy for each common mistake in the field
impement an effective clinical strategy, including solutions based on AI and Machine Learning