ABOUT
About Dalia Givony
Dalia Givony is the Founder and Principal Consultant of Dalia Givony Regulatory & Clinical Consulting, providing strategic regulatory and clinical consulting services to medical device, IVD, AI Software as a Medical Device (AI SaMD), and digital health companies worldwide.
With more than 20 years of experience in the medical device industry, Dalia helps innovative companies successfully navigate complex global regulatory requirements and accelerate market access.
Before establishing her consulting practice, Dalia held executive leadership positions at Medtronic, where she led multidisciplinary teams and developed global regulatory and clinical strategies supporting product development throughout the entire product lifecycle.
Dalia holds a Master of Science (M.Sc.) in Biomedical Engineering from the Technion – Israel Institute of Technology. Her unique combination of engineering, regulatory and clinical expertise enables her to bridge technology, clinical evidence and global regulatory strategy, helping clients make informed development decisions while reducing regulatory risk.
Over the past several years, Dalia has developed extensive expertise in AI Software as a Medical Device (AI SaMD) and digital health technologies, supporting companies developing AI-powered medical imaging, clinical decision support, digital pathology, cloud-based medical software and other innovative healthcare technologies.
Her experience spans global regulatory frameworks, including the U.S. FDA, European Union MDR, IVDR and EU AI Act, as well as regulatory pathways in Canada, Australia, the United Kingdom and Israel.
Clients value Dalia for her strategic thinking, collaborative approach and ability to translate complex regulatory requirements into practical solutions that support innovation, compliance and successful global commercialization.
