What is a risk analysis?

A risk analysis is a systematic process used to identify and evaluate potential risks associated with a medical device. It involves assessing the types of hazards that may arise during the device’s lifecycle, including its design, manufacturing, use, and post-market surveillance. The focus is on understanding how these risks could affect the safety and effectiveness of the device for patients and users.

In the context of regulatory affairs, risk analysis is vital as it supports compliance with various regulations, such as the FDA's Quality System Regulation and the ISO 14971 standard, which is specifically dedicated to the application of risk management to medical devices. This analysis can involve both qualitative and quantitative methods to determine the probability of occurrence of potential hazards and the severity of harm that could come from them.

The identification and evaluation of risks is essential for ensuring that devices are safe for consumer use and for mitigating any identified risks through appropriate design controls, labeling, or manufacturing practices. It also forms a critical part of the pre-market submission documentation to regulatory bodies, ensuring that the device meets safety and efficacy standards before it reaches the market.