Risk Management in Medical Device Development

This guide outlines the principles and processes of risk management in the context of medical device development. It begins by defining risk management as a set of activities aimed at ensuring the safety and effectiveness of medical devices for patients and operators. The document describes the importance of risk management, emphasizing ethical principles, legal requirements, and the necessity of understanding product use to prevent failures and reduce liability. It details the risk management process throughout the product lifecycle, from concept to decommissioning, highlighting key activities such as hazard identification, risk evaluation, and control measures. The guide also discusses the correlation between risk management and design control, indicating that both are essential for producing safe and effective devices. Additionally, it references relevant standards, such as EN ISO 14971:2019, which provides a framework for applying risk management to medical devices. The document serves as a comprehensive resource for manufacturers to implement effective risk management strategies.