Regulatory, Clinical & Quality Affairs for the MedTech Industry

©2019  H.M.Da Consulting & Development Ltd.

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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, manufacture 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

Shlomi Harpaz

Senior Project Manager and CSO

Shlomi Harpaz, M.Sc. M.A., is a Senior Project Manager at HaMaDa Consulting and Development. Shlomi brings HaMaDa hands-on experience in establishing and auditing quality management systems; risk management; documentation of design process activities; regulatory strategies and regulatory submissions. His unique interdisciplinary background (he has both an M.Sc. in Biomedical Engineering and an M.A. degree in History) allows him to effectively harmonize the demands of cutting-edge science and technology with the requirements set out in regulations and in standards. Shlomi is also an experienced tutor, well versed in the art of explaining both complex scientific concepts and regulatory and quality requirements.

Galit Berler

Senior Project Manager - QA

Galit Berler, B.Sc. in Materials Engineering and B.A 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 a 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 the methods and processes and the inter-personal communication and for creating a more pleasant and supportive work environment that helps achieving the 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.

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.

Lilach Segal

Senior Project Manager - RAQA

Lilach Segal, B.Sc. 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 held for 2 years a Quality director position 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.

Sivan Elizarov

RAQA Specialist and CRA

Sivan Elizarov, B.Sc., 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.

Racheli Peretz Ben-David

Senior Project Manager - RAQA

Racheli Peretz Ben-David, B.Sc 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 5 years of working experience in the field of Semiconductors. In the Medical Devices industy, Racheli gained experience in the Clean Rooms procedures, Validation of Processes and European Regulatory Bodies audits for CE and MDSAP approval.

Elinor Barzilai

Senior Project Manager - CRA

 

Elinor Barzilai, M.Sc., 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 B.Sc 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 B.Sc in Political Science and the History of the Middle East and Africa, M.Sc in Mass communication. Nili is also a Personal Trainer.

Miriam Rotenstein

Digital Media Manager

Miriam Rotenstein has an extensive background in Corporate Digital Traing and Knoweldge Managent Implementation both in the High-Tech industry and the Academia. Miriam holds a B.Sc in Economics and M.Sc in Educational Technology

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