The team at BioMedical Strategy group apply their deep and diverse experience to develop creative, efficient and cost effective regulatory pathway to introduce your product to new global markets.
Tami Harel, D.Sc.
Project Development, Clinical & Regulatory Affairs Expert
Dr. Harel is a clinical and regulatory affairs specialist with over fifteen years of experience in various positions in the medical device industry. Over this time, Tami has led global clinical and strategies, clinical trials activities, regulatory affairs submissions and quality system management worldwide (USA, EU, Asia, IL).She holds an D.Sc., and a M.Sc., in Biomedical Engineering from the Technion-Israel Institute of Technology, where she published her scientific publications.
Tal Bresler, Ph.D.
Regulatory Affairs and Quality Assurance Consultant
Tal is a Regulatory Affairs and Quality Assurance consultant with more than 13 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.
Liat Schwartz, Ph.D.
Clinical & Regulatory Affairs Consultant
Liat graduated with PhD 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.
Medical Device QA/RA Consultant
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.
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 the 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.
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 postmarket 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.
Clinical, Regulatory Affairs & Quality Control Expert
Rina Lev, Ph.D.
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 field that included among others, 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.