About Dalia Givony
Ms. Givony is a regulatory and clinical affairs professional with 20 years of experience in global regulatory and clinical studies of medical devices including executive RA & Clinical management position for 7 years at Medtronic.
Ms. Givony holds master degree of Biomedical Engineering from the Technion (Haifa, Israel) and has deep understanding of development processes, risk management, user & business needs as well as clinical environments.
Proven Experience in direct communication and negotiation with FDA, CE and other regulatory authorities to reduce the regulatory burden and V&V requirements.
Specializing in innovative, creative, less burdensome regulatory strategies, while taking into consideration other business aspects.
Plan and manage cost-effective pre & post market clinical studies to support 510(k) submissions and EU requirements as well as the expansion into new markets.