Sarit Gelbart Gal-Rom

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

Naida Gurshumov

Senior Project Manager - CL

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.

Elisabeth Sadka

Senior Project Manager - QARA

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. Comprehensive understanding of customers' needs and market requirements. Extensive experience in the areas of minimally invasive surgery and cryoablation

Galit Berler

Senior Project Manager - QA

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.

​Dr. Shay Faitelzon

Senior Project Manager

Dr. Shay Faitelzon has over 15 years of cross-disciplinary expertise in medical device product development management, including marketing, clinical affairs, international regulation and quality assurance. Dr. Faitelzon is a Veterinary Doctor and MBA graduate with vast knowledge in human medicine, broad professional experience, and a profound understanding of biomedical business processes and medical technologies development that brings vision, ingenuity and a comprehensive perspective to every project. In HaMaDa Ltd he serves as a senior project manager to medical device companies, in parallel he is a co-founder in CardioLogic Innovations, and the head of the Sapir Biodesign Program and a lecturer in the Technology Marketing Department, Sapir Academic College. Among his previous positions included Tulip Medical, Surgix, and SuperDimension (acquired by NYSE: MDT).

Daniele Perl-Treves

​Senior Project Manager

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.

Lilach Segal

Senior Project Manager - RAQA

Lilach Segal, BSc. in Biology and CQE certified has more than 25 years of experience as a Quality Assurance and Regulatory professional in the Medical Device and pharmaceutical Industries. Prior to working at HaMaDa Lilach was a Quality director for two years in a large global pharma company and for 15 years was the owner of a consulting company providing Regulatory, CE submissions and QA services for medical device start-ups ISO 13485, MDR/ QSR Regulations.

Roni Frankel

​Senior Project Manager - QA

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.

Hadas Weiss

Senior Project Manager - CL

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.

Racheli Peretz Ben-David

Senior Project Manager - RAQA

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.

Anat Marom

Project Manager - QACL

Anat Marom, PhD., has several years of experience in RA and Clinical Manager with non-invasive devices measuring optically various physiological parameters. Anat unique understanding in R&D and in clinical and regulatory affairs, allows her to effectively prepare regulatory submissions, and conduct clinical trials and development studies, working closely with the R&D staff. Anat is a certified CRA and holds PhD degree from the Technion and MSc degree from the Weizmann Institute of Science.

Livnat Bakal

RAQA Specialist

Livnat Bakal, MSc in Medical Sciences, has a 3 years’ experience in the Medical Device industry in the field of SW development life cycle, documentation of design process activities and QA & RA processes. She also has two years of working experience in SW V&V of complex medical systems.

Sivan Elizarov

RAQA Specialist and CRA

Sivan Elizarov, BSc in Biotechnology Engineering has a broad experience in both QA and Validation processes in Medical device and Pharma industries, focusing on supply chain area (GMP,GDP,GSP). Sivan possesses excellent skills in performing process optimization accompanied by writing procedures/customized work instructions and flow charts.

Elinor Barzilai

CRA

 

Elinor Barzilai, MSc in Biology has more than 8 years' experience as a clinical research coordinator accompanying clinical study at all stages and managing full study requirements such as submissions to MOH and IRB/EC and working with CRFs. Elinor is working effectively with clinical investigator and staff and has a strong understanding in GCP. She is also a certified Lab Technician and a CRA.

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.

Nili Talmi

Office Manager and personal assistant

Nili Talmi serves as HaMaDa office Manager and as the personal assistant for Sarit Gal-Rom. Nili has BSc in Political Science and the History of the Middle East and Africa, MSc in Mass communication. Nili is also a Personal Trainer.

Miriam Rotenstein

Digital Media Manager

Miriam Rotenstein has an extensive background in Corporate Digital Training and Knowledge Management implementation both in the High-Tech industry and the Academia. Miriam holds a BSc in Economics and MSc in Educational Technology

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Regulatory, Clinical & Quality Affairs for the MedTech Industry

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