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Complimentary Webinar
ON DEMAND RECORDING

Recorded on December 16, 2022 | 11:00 a.m. - 12:00 p.m. EDT

The Benefit and Risk of AI Software in Medical Devices

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Join us for a panel discussion on the benefit and risk of AI software in medical devices. The webinar will cover the key concerns, challenges, and common non-conformities that manufacturers, consultants and Notified Bodies are seeing from the application stage to final approval of medical device software. 

Learning Objectives:

• MDR Requirements 
• When a Clinical Evaluation of Software is required 
• Guidance Document MDCG 2020-1
• The clinical evaluation Process for MDSW 

SPEAKERS

Dr. Bassil Akra
CEO
AKRA Team GmbH

Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a consultancy company supporting medical device, in-vitro diagnostic, combination device companies preparing their strategy for the EU regulations MDR 2017/745 and IVDR 2017/746. Dr. Akra spent many years as a subject matter expert as well as the Head of Clinical for TÜV SÜD Product Service GmbH. Dr. Akra also served as the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has long experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standard. He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving the relevant designation ensuring continuity of the healthcare system in the interest of the patient population.

Robert Dostert
Sales Manager Medical Devices
DNV Business Assurance AS

Robert has 20 years of experience in the Healthcare industry. At DNV, Robert collaborates with a team of more than 250 experts, who serve the medical device industry worldwide. Robert is driven to ensure DNV's clients are provided quality services including assessments, CE Marking, software tools, training, and technical expertise to successfully bring their products to the healthcare market in a safe and timely manner.

Angela Lanna
Specialist-Healthcare & Medical Devices
DNV Product Assurance AS

Angela has more than 20 years’ experience working as a product specialist for DNV Product Assurance AS. She has long experience in leadership, team building, research, development, quality management, and regulatory approval of medical devices. During her time with DNV, she has worked as a product specialist and technical reviewer. Angela is currently supporting a research team developing AI software tools to help improve DNV’s processes.  

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