Medical Device Risk Management File

The fda recognizes iso 14971 2007 as the standard for risk management of medical devices.

Medical device risk management file.

Risk management uses policies procedures and practices to systematically analyze evaluate control and monitor risk. 2 23 risk management file. Paper form electronic form and in folders on condition that it. With the help of a risk management system based on iso 13485 and iso 14971 each phase of a risk management cycle is documented comprehensively to demonstrate the manufacturer s commitment to controlling risk in the life of the medical device.

Iso 14971 medical devices application of risk management to medical devices is an iso standard for the application of risk management to medical devices. The purpose of iso 14971 is to help manufacturers to establish a medical device risk management process that can be used to identify hazards to estimate and evaluate risks and to develop implement and monitor the effectiveness of risk control measures. Its purpose is to enable easy and quick access to the risk management artefacts and it can take any form e g. As i go through this guide on medical device risk management i will often reference the iso 14971 standard the reasons for this are described earlier in this guide.

A risk management file must be created for each medical device. All these activities and results are recorded in the risk management file. Medical device risk management 17 a brief discussion of software risk management 1 tr 80002 1 4 4 3. It requires that a company establish a risk management policy.

Medical device risk management requires top management involvement. Contains nonbinding recommendations 1 guidance for industry1 q9 quality risk management this guidance represents the food and drug administration s fda s current thinking on this topic. The creation of a risk management file rmf is one of the earliest actions in the risk management process. Management commitment to control risk of a medical device.

Therefore it is not uncommon for a product that is already 510k cleared to receive audit nonconformities related to the risk management documentation during a technical file review by a notified body. This file is a repository of the risk management artefacts. Iec 62304 2006 amd1 2015 b 4 3 software anomalies in a particular version of software will be present in all copies of that software.