Daniel Albahari, M.Sc., RAC
Founder & Principal Consultant

Head of EU & Israel Medical Device Department

Since 2016, after working as a Regulatory Affairs Manager for several medical device companies in Israel for ten years, Daniel set up a boutique regulatory consultancy, BioReg Services.
Daniel Albahari has more than 17 years of hands-on experience in the medical device and healthcare industry, consulting for local and international companies focused on regulatory and quality issues relating to medical devices and combination products for marketing in Europe, the US, and Israel. Daniel has provided consulting for diverse healthcare products, including Medical Devices, Biotech, Software, Image Navigation, Botanical Combinations, Personal Protective Equipment (PPE), Pharma, New Molecular Entities (NMEs), Cosmetics, and others.
Daniel’s specialties include Medical device regulatory strategy & submissions, MDR CE marking, MDD-MDR transition, Clinical Evaluation (CER), Post-marketing strategy (PMS & PMCF), Person Responsible for Regulatory Compliance (PRRC) service, Israel Registration Holder (IRH) service, ISO 13485 Quality Systems, Quality Agreements, 510K submissions & FDA audits, regulatory training and education.
Daniel successfully negotiates innovative and cost-effective regulatory solutions with EU-notified bodies, competent authorities, and the U.S. FDA. He and his colleagues have obtained dozens of MDD and MDR CE markings for all product classes, and numerous FDA 510(k) and Israeli AMAR approvals.
Daniel holds a B.Sc. in molecular biology and physiology from the University of Belgrade, an M.Sc. in structural & molecular biochemistry from the Hebrew University of Jerusalem, and a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society.