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IVD Regulation and Software
November 5 - 7, 2024
Digital Conference8:00AM CST // 9:00AM EST // 2:00PM GMT

Arun Mathew
Associate Director, Quality Systems (Risk Management) at AbbVie
Speaker

Profile

Arun is a highly skilled and experienced Risk Management professional with a wealth of knowledge and expertise in the field. He holds a master's degree from Coventry University, an executive Master of Business Administration from Quantic, and a Diploma in Electronics. Arun has led corporate-level teams in establishing robust Risk Management processes and procedures. His pioneering risk-based approaches have been implemented in design control, verification and validation, process validation, CAPA, change management and other quality management systems. Arun is an active member of the American Society for Quality and holds certifications as a CQA Certified Quality Auditor, CQE Certified Quality Engineer and Risk Management credential. Currently, Arun works as Associate Director, Quality Management Systems (Risk Management) at AbbVie.

He is a co-author of the book Mastering Safety Risk Management for Medical devices and Invitro Devices released by ASQ.

Agenda Sessions

  • Risk Management Framework for AI in Medical Devices

    11:10