AFDO RAPS Healthcare Products Collaborative
BIO
Banta Bob

Bob

Banta

Associate Senior Consultant - QA

Eli Lilly

In his current role, Bob authors global medical device quality standards and common quality practice documents. He also provides oversight to changes to the Lilly device QMS in order to support Lilly digital device initiatives (including AI/ML-based SaMDs). Bob also provides global device quality support with respect to medical device QMS auditing, risk management governance including medical device cybersecurity risk governance, product lifecycle management (PLM), and device regulatory surveillance. He has twice presented at past FDA/Xavier University Global Medical Device Conferences on SaMD QMS and risk management. He is a member of the AAMI Device Security Working Group (SM-WG05 – Device Security WG) which was responsible for authoring AAMI TIR97:2019/Ed.1 Principles for medical device security – Post-market security management for device manufacturers; the SM-WG05 Group is currently drafting a proposed new American National Standard—AAMI SW96, Standard for medical device security—Security risk management for device manufacturers. Bob is also a member of the AAMI Artificial Intelligence (AI) Committee. He has worked for Lilly for the past 19 years with prior extensive experien

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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