Page 46 - Safety Risk Management for Medical Devices

CHAPTER 6

Requirements of the Risk

Management Process

Abstract
ISO 14971 offers a framework for managing the risks of medical devices. Rather than being prescrip-
tive, this framework has specific requirements and expectations.
Keywords: Risk management process

ISO 14971 [3,7] offers a framework for managing the risks of medical devices. Rather than
being prescriptive, this framework has specific requirements and expectations. Namely:
• Have a documented process, and apply it to the entire product lifecycle
• Have a plan
• Use qualified personnel to perform risk management
• Ensure completeness of Risk Controls for all identified risks
• Evaluate the overall residual risk
• Show that the benefits outweigh the risks
• Monitor production and postproduction information and feed that back into
the risk management process
• Produce a risk management report
• Create and maintain a risk management file
• Show traceability among Hazards, risks, risk analysis, evaluation and control,
and verification of Risk Controls
The manufacturer is free to create the internal processes to meet the above requirements.

6.1 RISK MANAGEMENT PROCESS

The risk management process should have at least the following element:

6.1.1 Risk analysis
The requirements for risk analysis are:

• Provide a description and identification of the medical device under analysis
• Define the scope of analysis—what’s included and what’s excluded

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00006-4 All rights reserved. 25