About Elle, MD

Shifra Hoch, MSc is a regulatory consultant with over 15 years of experience in medical device and drug-device combination product regulation. She specializes in navigating the regulatory environment to bring new medical devices to the market in the Canda, US, EU, and ROW. Drawing from her experience in both startup companies and established global manufacturers, she offers creative solutions tailored to customer needs, balancing the demands of the fast-paced startup environment with consideration of the long-term effects of early decisions. With her experience in management roles, she provides strategic guidance that aligns with the company’s overarching objectives.

As a Regulatory Lead to Elle, MD, she advises on regulatory planning, technical file development, and submission preparation.