Current Edition

Clinical Trials in Medical Devices: Life Cycle Risk Management

Risk refers to the chance of suffering loss or injury, or anyone proposing a hazard. The process of risk management identifies, evaluates and prioritises potential hazards, then applies initiatives and resources to minimise, coordinate and manage the possibility of hazards occurring, and to lessen the effect of any concerns. Balamuralidhara. V, Prasannakumar P Bhat et al. at JSS College of Pharmacy describe the fundamental principles of project risk management, and how clinical information can be used to manage risk in medical device projects.