Abhineet JhoriRegulatory Affairs Manager at Siemens HealthineersSpeaker
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
Workshop Leader Opening Remarks
, 08:30View SessionChairperson’s Afternoon Remarks: EU AI Act Workshop
, 14:10View SessionPerfecting Predetermined Change Control Plans (PCCPs)
, 11:10View Session