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Our Team

The team at the BioMedical Strategy group applies their deep and diverse experience to develop creative, efficient, and cost-effective regulatory pathways to introduce your product to new global markets.

Orna
Rina
Batya
Anna
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Orna Oz, Ph.D.

Founder & CEO

Dr. Orna Oz is a Clinical and Regulatory Affairs specialist with more than twenty-five years of experience in the Regulatory, Pre-Clinical, and Clinical research fields. In academia (as a senior researcher), as well as in the medical industry, Orna has led multidisciplinary research projects and teams, gaining vast experience in project Strategic Planning, Pre-Clinical Testing (bench and animal), Clinical Studies, and Regulatory submissions.
She holds a M.Sc., in Mathematics and Natural Sciences from The University of Rome, and a Ph.D. in Physics (Medical Physics) from Tel Aviv University, where she published her pioneering research in the field of linear and non-linear, time and frequency domain, signal analysis of hemodynamic parameters for the analysis of the cardiovascular control mechanisms.
After her long academic experience, as a senior researcher, Dr. Oz joined in 1996 the biomedical industry.

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Rina Lev, Ph.D.

Executive Manager,

Clinical, Regulatory & Quality Expert

Dr. Lev is a Scientific Regulatory and Clinical Affairs consultant with over twenty years of experience in the Medical Device industry.  During this time, Rina has led multidisciplinary projects in the Clinical, Regulatory, and QA fields that included among others, the preparation of Clinical and Regulatory Strategies (IL, EU, US, China), Clinical Evaluation Reports (EU), management of Clinical Trials activities worldwide and Quality System management (Quality planning, CAPA, Risk management). Rina has a broad scientific background, she holds a M.Sc., in Clinical Biochemistry from Tel Aviv University and a Ph.D. in Clinical Neurophysiology from the Faculty of Medicine from the Technion, where she published her scientific work.

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Batya Barkan, Ph.D.

Clinical & Regulatory Affairs Expert

Dr. Barkan is a Scientific Regulatory and Clinical affairs consultant with experience in the Regulation of Medical Devices in the U.S. and Europe. Batya has vast gained experience preparing and supporting Regulatory submissions, Clinical Studies, Clinical Evaluation Reports, and other scientific reports supporting the scientific, technological, and clinical demonstration of developing products as well, as Post-Market Surveillance information. Batya holds a M.Sc in Neurobiochemistry and a Ph.D. from the Department of Neurobiology, Life Science Faculty of Tel Aviv University.

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Anna Sterkin, Ph.D.

Scientific Expert

Dr. Sterkin has extensive experience in clinical research & medical device development of more than 15 years. Anna has conducted academic research in the field of clinical neuroscience, yielding methodological developments in neurophysiology and behavior in healthy subjects and patients, including newborn VEP, Event-Related Potentials (ERP), Functional Magnetic Resonance Imaging (fMRI) and eye tracking. Her research focused on neuro-physiological substrates, development, and rehabilitation of the visual perception under normal conditions and following pharmacological manipulation. Anna has also led preclinical and clinical stages of medical device development in the industry and served as a regulatory clinical reviewer and scientific expert. Anna holds a Ph.D. in Brain Research from the Weizmann Institute of Science.

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Tal Bresler, Ph.D.

Regulatory Affairs and Quality Assurance Consultant

Dr. Bresler is a Regulatory Affairs and Quality Assurance consultant with more than 15 years of experience. Tal started her way in the academic world and holds a Ph.D. in Neuroscience. After completing her Ph.D., she joined the biomedical and later the Medical Device industries and managed Regulatory Affairs and Quality Assurance teams in various companies. Tal was responsible for dozens of successful Regulatory applications in different markets worldwide and participated in many audits, so has a deep understanding of Auditor expectations. In 2017 she established her independent consulting firm located in Toronto Canada providing tailored Regulatory Affairs and Quality Assurance solutions for Medical Device companies worldwide.

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Elena Boim 

Regulatory Affairs & Quality Control Expert

Elena has over twenty years’ of experience in strategic planning, developing and implementing Quality controls (QMS) in numerous and various Medical Device companies. She has a proven comprehensive knowledge and understanding in the field of Medical Device Standards and Regulations, critical when establishing QMS and successfully completing worldwide leading Regulatory Authorities audits. She has proven experience in QMS establishment and compliance maintenance, OBL process, Design Control and Risk management, outsourced production processes, QMS software validation as well as statistical methods implementation. Elena holds a Master’s Degree in Physics from the Saratov State University (Russia), CQT Certificate (Certified Quality Technician) from the American Society for Quality, ICQT Certificate (Israeli Certified Quality Technician) from Israeli Society for Quality, Six Sigma and Lead Auditor Certificates.

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Liat Schwartz, Ph.D.

Clinical & Regulatory Affairs Consultant

Dr. Schwartz graduated with Ph.D. in Medical Sciences from the Technion in Haifa, having also a background of Electronic and Bio-Medical Engineering. Due to her background, her career focused on Medical Devices development, as for example in applications for cardiac electrophysiology and orthopedics. Particularly, she has vast experience in Pre-Clinical Studies (animal models), Regulatory Affairs and Strategy planning, Clinical Studies, preparation of files for QA and Regulatory Submissions and intellectual property development. She has few articles published in professional journals and is co-inventor in few allowed patents in the field of Medical Devices development.

Tal
Elena
Liat
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