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Regulation, Clinical and Software for Medical Devices

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November 5 - 7, 2024
The Royal Sonesta Minneapolis DowntownMinneapolis, Minnesota

Abhineet Jhori
Regulatory Affairs Manager at Siemens Healthineers
Speaker

Profile

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 and IEC sub-committees.

Agenda Sessions

  • Learnings of Machine Learning: Where Are We with Regulating Artificial Intelligence and Machine Learning (AI/ML)

    8:55am