Article Context:
Risk Management Plan
A Risk Management Plan is a written document with details of the Risk Management Process for a medical device. Risk Management helps to check on any product-related issues. In addition, risk management is a tool that allows us to design, develop, and manufacture safer medical devices.
Important facts about ISO 14971
ISO 14971 is the standard for medical devices and is used worldwide. ISO 14971helps to identify, evaluate, and resolve any dangers or untoward occurrences associated with the use of medical devices. It is used across the industry to ensure product safety requirements are met. This article is a gist and is an overview of the standard, but not the standard by itself, and may be used for reference purposes.
A quality management system is a risk management system that helps the manufacturers to understand the risks involved in the lifecycle of a medical device.
ISO 14971 does not require implementing a separate quality management system as risk management is integral to an effective quality management system.
Complying with ISO 14971 would mean establishing and maintaining a risk management system all through the product lifecycle, from the planning, implementation, and usage of the products is recorded and stored in a risk management file.
The most important stages like risk analysis, evaluation, and control are undertaken in the overall Risk Management System. It is left at the manufacturer’s discretion to ascertain the standard levels for the products he manufactures. However, a standard guideline is designed for developing a risk management system, ISO 14971compliant.
Risk Analysis in Risk Management System
In Risk Management System, the manufacturer is expected to document or have a record of risk analysis activities in a risk management file, and the file should include the following:
- Guidelines for usage of the device and indicated results of the misuse of the device
- Known and unforeseeable Challenges or Hazards
- Calculate the level of Risk when it occurred and the duration and frequency of the hazard occurrence.
Risk Evaluation in Risk Management System
Risk Evaluation is the process of evaluating the occurrence of any hazard. Therefore, the manufacturers must analyze both the hazard’s probability and impact.
A risk evaluation matrix, such as the following example, is often used to visualize risk acceptability. The basic steps for Risk Evaluation are as under:
- Identification
- Probability of occurrence and the Impact
- Moment of Risk
- Treatment
- Monitoring and Review
Risk Control in Risk Management System
In Risk Management, the manufacturer must have standard operating procedures in place in case of any hazard of an unacceptable risk level. In such cases, it becomes even more important that this structure incorporates the best use of technology, information, and knowledge. Risk control options can be laid down as follows:
- Safety for both designing and manufacturing
- Protective steps undertake during the design and also during manufacturing
- Providing appropriate safety information to the end users.
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