Management and team
Our highly educated professional staff has an extensive FDA, industry, and clinical studies experience. We have a thorough understanding of medical device development and testing, health authorities' approval processes and compliance and quality assurance systems.Yoram Levy, BSc - Regulatory Affairs, R&D and Quality Management
Yoram Levy is an Electronic Engineer with a long time experience in R&D of high tech projects, VP R&D and VP of QA and Regulatory of international medical devices companies. He has a wide experience and connections with the important regulatory agencies worldwide. Yoram has built global quality systems, prepared FDA, CE and other international submissions and has led many FDA, CE and ISO audits worldwide.
Dr. Hanna Levy - Clinical Research and Statistical Analysis
Hanna Levy has a PhD in Physiology and Biophysics and years of experience in clinical research and biostatistics. She has widespread knowledge in clinical and pre-clinical study management, including clinical protocol and CRF design, clinical regulatory forms, statistical analysis and scientific writing.
Dr. Moshe Etzion - Regulatory Affairs
Moshe Etzion has a PhD in Engineering Physics.
He has over 10 years of extensive FDA and other medical device submissions.
Moshe has many years of experience in R&D, project and manufacturing management, marketing and technology transfer.
Dr. Efrat Hartog-David - Regulatory and Clinical Research
Efrat Hartog-David has PhD in Biotechnology and Food Engineering from the Technion Institute. She has a broad scientific background and experience in scientific writing. Efrat has gained experience in clinical and regulatory affairs including regulatory strategies and submissions, and pre-clinical and clinical study design.
Suhair Francis-Najjar, BSc - Software QA
Suhair Francis-Najjar is a mpliance with emphasis on software verification and validation, software quality assurance, software development procedures, and project planning and management.
She has held a number of technical and managerial positions in the area of software development of medical devices for over 20 years. She is a Six Sigma Green Belt, and specializes in design for software reliability.
Ofer Levy BSc - Quality Assurance
Mechanical engineer with experience in design and medical device compliance
Anat Lisianski, BSc - Regulatory Affairs
Electronic Engineer with experience in design and medical device compliance
Diana Pinchev, BSc - Quality Assurance
Design and maintain quality systems according to the FDA QSR, ISO standards and CE MDD.
Boaz Levy, BSc - Software QA
Software Engineer specialized in software compliance with emphasis on
software verification and validation, software quality assurance and
software development procedures.
