An increasing number of medical devices and invitro diagnostics incorporate artificial intelligence (AI) to support therapeutic and diagnostic applications. In spite of the risks connected with this innovative technology, the applicable regulatory framework does not specify any requirements for this class of medical devices. To make matters even more complicated for manufacturers, there are no standards, guidance documents or common specifications for medical devices on how to demonstrate conformity with the essential requirements. This presentation explains the common risks and pitfalls of incorporating AI in medical devices and gives an outlook on the regulatory framework.
Dr. Abtin Rad
Global Director Functional Safety & Software
Dr. Abtin Rad has 13 years of professional experience as a Biomedical and electrical Engineer with focus on Software, Cybersecurity and Artificial Intelligence, as well as medical Imaging and Therapy using Ultrasound and optical laser systems. Dr. Abtin Rad is a Cybersecurity and Artificial Intelligence Specialist for medical devices and medical software, as well as a Lead Auditor for ISO 13485, ISO 9001, MDSAP and MDD/MDR