What document outlines risk management in the context of product lifecycle?

The Risk Management Plan is the document that specifically outlines the approach to managing risks throughout the product lifecycle. It provides a structured framework for identifying, assessing, and mitigating risks associated with a product from its initial development through to its post-market phase. This plan ensures that risks to patients, users, and other stakeholders are minimized and that strategies are in place to monitor and address risks as they arise.

In the context of product development and regulation, the Risk Management Plan is essential for compliance with international standards such as ISO 14971, which governs the application of risk management to medical devices. This document serves not only as a roadmap for managing risks but also demonstrates to regulatory bodies that the manufacturer takes the safety and effectiveness of their product seriously.

The other documents listed serve different purposes. A Trial Protocol details the plans for conducting clinical trials and does not inherently focus on risk management processes. A Quality Assurance Report assesses compliance with quality standards and practices, rather than specifically addressing risk management. A Safety Data Sheet provides information on the properties of chemical substances or mixtures but does not cover the holistic risk management strategy necessary for product lifecycle management.