Nimrod Epstein

Nimrod Epstein, PhD has a strong background in regulatory affairs and quality management in the field of medical devices. Nimrod has held various positions in different companies where they have contributed to the development and implementation of effective regulatory strategies and quality management systems.

Their most recent role was as the Head RA at Imagene AI, starting in June 2022. Prior to that, they served as a GVI, Medical Device Regulatory/Quality Expert (RA/QA) at Gold Ventures Incubator from January 2018 onwards. In this role, they were responsible for regulatory strategy definition, including the use of artificial intelligence and deep learning algorithms for analyzing radiological images and developing computer-assisted triage software. Nimrod also tailored the quality management system (QMS) to meet the company's needs.

From May 2018 to May 2022, Nimrod worked at Aidoc Medical as the Head of Regulatory and Quality. During their tenure, they played a key role in ensuring regulatory compliance and maintaining quality standards.

Prior to that, at G Medical Innovations, they held the position of Regulatory & Quality Manager from September 2016 to February 2018. In this role, they successfully submitted multiple Pre-Market Notifications (PMNs) and Technical Files to the FDA and CE, leading to clearances and addressing review questions.

Nimrod also served as the RA/QA Manager at VASA Applied Technologies from December 2013 to 2016, where they constructed the QMS from scratch and obtained ISO 13485 certification. Nimrod led the preparation of the Technical File and CE Mark for the Feedback Breastfeeding Meter and completed the FDA 513g process.

Nimrod has earlier experience as well, including positions such as QA/RA Manager at Azimuth Therapy Ltd., QA Manager at Sensible Medical Innovations Ltd., and RA/QA Director at NeatStitch Ltd. In these roles, they made significant contributions to regulatory submissions, quality system improvement, and the successful approval of device modifications.

From October 2006 to February 2011, Nimrod served as the RA/QA Director at S.L.P. ltd. where they were responsible for maintaining and certifying the company's quality system to ISO 13485 and 9001 standards. Their responsibilities also included regulatory submissions, device classification, registration, labeling, risk management, and the maintenance of the Design History File.

Nimrod began their career as a Project Manager, QA/RA Medical Device at Medicsense Ltd.

Overall, Nimrod Epstein, PhD has extensive experience in regulatory affairs and quality management in the field of medical devices, having held various positions in different companies. Their expertise includes regulatory strategy, quality management system implementation, and successful regulatory submissions for both FDA and CE approvals.

Nimrod Epstein, PhD, has a strong education background in biology. In 1997, they attended the University of Amsterdam where they pursued their PhD in Biology with a focus on the physiology and ecology of reef corals, as well as the active restoration of reefs. Their studies lasted for three years, until 2000.

Before pursuing their PhD, Nimrod Epstein attended the Technion - Israel Institute of Technology from 1980 to 1984. Although the degree name is not specified, they studied a field of study known as "biology" during their time there.

In addition to their academic degrees, Nimrod Epstein also obtained a certification as a Lead Auditor 13485 from SII - the standards institution of Israel. However, the specific month and year of obtaining this certification are not provided.