The 12th Annual Medical Device Regulations Conference (MDRC) brings together key stakeholders in the medical device industry and the FDA to share insights and advancements that would support small businesses and innovation hubs in academia. The growth of the medical device industry is driven by small businesses that play a pivotal role in revolutionizing healthcare through groundbreaking technologies and solutions. Medical device regulations are constantly evolving, and it is a challenge for small businesses within the medical device industry to keep themselves current. This year’s MDRC will include the topics related to the upcoming implementation of the Quality Management System Regulations (QMSR) final rule, understanding of the current and forthcoming FDA policies affecting the life-cycle of medical devices and regulatory landscape outside of the US for medical devices.