Senior Key expert AI and Regulatory affairs Manager
Siemens Healthineers
Masters in computer application.
20+ experience in software medical device industry.
Prior and current experience include quality management, product risk management, complaints management and Regulatory affairs .
Published papers accepted in ECR 2022.
Consultant to various modalities on process and requirements for conducting clinical investigations/ multi reader studies for AI based devices.
Develop strategies to clear AI based medical devices in various countries around the globe.
Author and senior Key Expert for various regulatory processes in the organization including AI/ML based devices.
Member and contributor for various industry associations and AI committees - MITA / MDCI
Disclosure information not submitted.
The EU’s AI Act: Understanding the challenges to AI-enabled Medical Devices conformity assessments
Tuesday, May 7, 2024
08:30 – 09:30 CEST