Nimrod Epstein, PhD. (Biology)

Nimrod Epstein, PhD. (Biology) has worked in various roles within the medical device industry since 2005. From 2005 to 2006, they were the RA/QA Director at S.L.P. Ltd., where they were responsible for the maintenance and annual certification of the company's quality system to ISO 13485 and 9001 standards, as well as regulatory submissions, device classification, Amar registration, labeling, risk management, and DHF. From 2006 to 2011, they were the RA/QA Director at NeatStitch Ltd., where they were responsible for all regulatory and quality aspects of a surgical device, and in that time period successfully passed the company's annual certification and improved numerous aspects of its quality system. From 2011 to 2013, they were the QA/RA Manager at Azimuth Therapy Ltd. From 2013 to 2016, they were the Regulatory & Quality Manager at G Medical Innovations, where they submitted 3 PMNs and 1 Pre-Submission to the FDA, got one clearance, and answered all other RTAs and Substantial review questions. Nimrod also submitted 2 Tech Files and 1 NoC to the CE, one of which was cleared, with review questions answered in the others. From 2016 to 2018, they were the Head of Regulatory and Quality at Aidoc Medical, and from 2018 to 2022, they were the Medical Device Regulatory/Quality Expert (RA/QA) and Medical Device Quality and Regulatory Consultant at Gold Ventures Incubator, where they were responsible for Regulatory Strategy definition, Artificial Intelligence, Deep Learning Algorithms for Analysis of Radiological Images, and Computer Assisted Triage Software, as well as QMS tailoring. Nimrod is currently the Head RA at Imagene AI.

Nimrod Epstein, PhD holds a PhD in Biology- physiology and ecology of reef corals, active restoration of reefs from the University of Amsterdam, which they obtained in 2000. Nimrod also attended \u05ea\u05d9\u05db\u05d5\u05df \u05e2\u05d9\u05e8\u05d5\u05e0\u05d9 \u05d3 \u05e2\"\u05e9 \u05e7\u05e6\u05d9\u05e8 from 1980 to 1984, studying \u05d1\u05d9\u05d5\u05dc\u05d5\u05d2\u05d9\u05d4. Additionally, they hold a Lead Auditor 13485 certification from SII-the standards institution of Israel.