About this document

ISO 13485 Risk Management Procedure by MarcBenetPozo is a document available to read on EtoBox.

This document provides a framework for a manufacturer to manage risks associated with medical devices. It outlines the risk management process, including risk analysis, evaluation, control and monitoring. Requirements apply to all phases of the device lifecycle from development through post-market activities. The goal is to help ensure medical devices are safe and effective for their intended use.

Author

MarcBenetPozo

Language

EN