Which type of documentation is essential during the lifecycle of a medical device?

The importance of risk management plans in the lifecycle of a medical device cannot be overstated. These documents are essential for ensuring the safety and effectiveness of the device throughout its development, manufacturing, and use. Risk management involves identifying potential hazards associated with the device, assessing the risks of those hazards, and implementing strategies to mitigate them. This process is not only a regulatory requirement for compliance with standards like ISO 14971 but also a fundamental practice that helps protect patients and users.

By consistently updating and evaluating the risk management plan throughout the lifecycle of the device, manufacturers can respond to new information, changes in intended use, and advancements in technology. This ongoing vigilance helps in maintaining product safety and efficacy, ultimately fulfilling regulatory obligations and supporting market access.

In contrast, while economic analysis reports, marketing brochures, and sales forecasting documents certainly play roles in the commercial aspects of medical devices, they do not hold the same level of critical importance in ensuring the safety and regulatory compliance of the product as risk management plans do. These other types of documentation serve different purposes, focusing primarily on financial viability and market strategies.