Impactul reglementărilor asupra inovaţiei şi siguranţei în domeniul biomedical

Abstract

This article explores the impact of regulations on innovation and safety in the biomedical field, examining how regulations influence innovation and safety through a comparative analysis of the global legislative framework. The study emphasizes the importance of regulations for patient protection and ensuring the efficacy of new biomedical technologies, while also highlighting the challenges they pose for innovators. The research underscores how regulations affect the development process of new biomedical technologies and the necessary balance between patient protection and the stimulation of innovation. The conclusions outline the importance of a harmonized and flexible approach to support progress in the biomedical field, while ensuring the safety and efficacy of products and procedures.