What is the purpose of the "Risk Management File"?

The purpose of the "Risk Management File" is to document all aspects of risk management activities associated with a medical device, including risk evaluation and mitigation strategies. This file serves as a comprehensive record that ensures systematic identification, assessment, and control of risks throughout the lifecycle of the device.

In the context of regulatory compliance, the Risk Management File is critical for demonstrating adherence to international standards such as ISO 14971, which outlines the process for risk management in medical devices. It plays a vital role in providing evidence that risks have been acknowledged, evaluated, and sufficiently mitigated to ensure patient safety and product effectiveness. A well-maintained Risk Management File not only enhances the quality of the device but also supports manufacturers during audits or inspections by regulatory bodies.

While assessing market potential, evaluating sales and marketing performance, or managing customer service inquiries are important business functions, they do not focus specifically on the systematic approach to risk and safety that is central to the effective management of medical devices.