Owner, CEO and Senior RAQA Consultant
Sarit Gelbart Gal-Rom, BSc, MBA, has extensive regulatory management experience in the Israeli Medical Device industry. Sarit previously held the position of VP RAQA at Galil Medical, a global company that develops, manufactures and markets innovative cryotherapy solutions for prostate cancer, breast fibroadenoma and other clinical indications. Sarit played an integral part in establishing, managing and operating Medical Compression Systems Ltd., traded in TASE, ID: 109689. MCS is an Israeli company that develops, manufactures and sells innovative compression systems for the prevention of Deep Vein Thrombosis. Sarit used to serve as a board member of Xenia Venture Capital traded on TASE, ID 1099571 and PCB Technologies traded on TASE, ID 1091685
CMO and QARA Consultant, Expert
Elisabeth Sadka M.Sc., MBA, has 20 years of managing experience in the medical device industry. Product development, international Regulatory affairs, QA Management and QMS implementation, Clinical management and Business development. Multidisciplinary background with extensive experience in working closely with physicians worldwide. Elisabeth also has comprehensive understanding of customers' needs and market requirements and extensive experience in the areas of minimally invasive surgery and cryoablation
RACL Conusltant, Expert
Daniele Perl-Treves, PhD, has more than 15 years’ experience in the medical device industry. Daniele was Clinical Director of Radiancy, a global company specializing in medical and aesthetic skin care devices. Prior to that Daniele was project leader at OrSense Ltd, developing light based devices for non-invasive hemoglobin and glucose determination. Dr. Perl-Treves holds MSc and PhD degrees from the Weizmann Institute of Science and completed a postdoctoral fellowship in Cornell University (NY). She is also a certified CRA.
CL Consultant, Expert
Naida Gurshumov PhD., has more than 20 years’ experience in the Clinical Research industry and scientific medical writing, leading various positions in pharmaceutical, medical device and CRO companies. Naida holds a PhD in Medical Sciences from Tel Aviv University.
CL Consultant, Expert
Hadas Weiss, MSc in BioMedical Engineering, has more than 15 years of experience in managing and executing projects in the Medical Device industry. Her experience includes leading and managing clinical trials worldwide and developing and preparing regulatory submissions. Hadas has extensive knowledge in ENT, Radiology, Oncology, Gynecology and functional Neurosurgery areas.
Galit Berler, BSc. in Materials Engineering and BA in Physics and a certified coach. Galit has extensive Quality Management experience in the Israeli Medical Device industry and extensive Engineering and Project Management experience from both the Israeli Medical Device and the Semiconductor industries. Galit held various management positions in Tower Semiconductors and Philips Medical Systems companies, and in the last years served as a QA/RA consultant in the Medical Device industry. She has vast experience and knowledge in process control, production and operations control and NPI (new product introduction) activities. Galit combines her knowledge, experience and vision as a personal and management coach in her QA/RA work, for improving methods, processes and inter-personal communication and for creating a more pleasant and supportive work environment that helps achieving business goals more easily, efficiently and with harmony.
Roni Frankel M.Sc, MBA, has extensive experience of over 13 years in establishing, improving, maintaining, and leading Quality Systems of Medical Device companies. according to regulatory and international quality standards. In her diverse roles, she was setting up and improving quality systems to ensure accreditation of CE mark and alignment with the Canadian and European regulations and audited contract research organizations to ensure GLP requirements are met. Roni also took a leading part in in identifying gaps between the QMS and newly introduced standards and regulations (such as ISO 13485:2016, and MDSAP) as well as defining ways to close identified gaps to ensure QMS full compliance. Roni holds Cum Laude M.Sc. in Neurobiology from the Hebrew University, Jerusalem, and MBA from the Technion - Israel Institute of Technology.
Noa Segall, PhD, is human factors engineer with over 15 years of experience in clinical research. Previously, she was an Assistant Professor of Anesthesiology in the Duke University School of Medicine, where she served as principal investigator for several multi-site clinical trials. She has extensive experience in usability testing and other human-centered design and evaluation tools for ensuring patient safety
Racheli Peretz Ben-David
Racheli Peretz Ben-David, BSc in Chemical Eng,. has a 10 years' experience in the Medical Device industry holding various responsibilities of QA & RA management routines. She also has additional five years of working experience in the field of Semiconductors. In the Medical Devices industy, Racheli gained experience in the Cleanrooms procedures, Validation of Processes and European Regulatory Bodies audits for CE and MDSAP approval.
Senior RAQA Consultant
Valentina Zhutovski, M.A. Statistics, is a Regulatory Affairs Specialist in the Medical Device Industry, specialized in obtaining regulatory approvals for medical devices classified Class II and III at global companies required compliance with International Regulations.
Adrian Javaherian, MSc. In Biology and Bioinformatics has 6 years of experience in the medical device industry, in both medical devices and in vitro medical devices. Adrian has established QMS systems for start-up companies, obtained ISO 13485 certification, CE marking under MDD, IVDD, and MDR, and AMAR certification.
Hadas Donio, M.Sc. in Applied Chemistry. Hadas has 20 years of experience in the pharmaceutical industries where she has gained a vast knowledge of the QA, registration, CAPA, investigations, qualification, working procedures and GMP fields.
Her previous work experience also include role as an R&D regulatory affairs project manager, working with FDA and the IL ministry of health.
Maya Yurista, BSc., in Geophysics and CQE certified has more than 12 years of Medical Device work experience serving as Quality Assurance Director, Mentor, and Projects Leader. Maya has a vast knowledge of standard implementation according to ISO, MDD/MDR requirements as well as performing Audits (Internal and preparation to NB and other regulations external audits.
Shai Ben Efraim
Business Development Manager
Shai Ben-Efraim, is a 20-year veteran of the Biomed sector. Shai is an entrepreneur who has established and managed five start-up companies, four of which are in the medical devices arena (CardioCom, CPR Devices, MediFlow and Magen OrthoMed). He has also held an active role as a senior advisor to various Start-ups, Technological Incubators and investors in this sphere. Shai is currently leveraging his extensive industry experience in order to create successful engagements between BioMed Service Providers and their potential customers. Shai holds a BSc in Economics.