ISO 13485: Risk Management and Analysis - Medical Devices

ISO 13485 - Risk Management and Analysis

ISO 13485

According to the Medical Device Regulation and ISO 13485 standard, which adopts risk-based production processes as a principle, all processes affecting the safety and performance of the medical product should be planned and managed based on risk analysis.

The risk file for medical devices is created based on the ISO 14971 standard. While creating the Risk Analysis File, it is necessary to master all relevant standards, regulations and clinical data related to the medical product. While creating the Risk Analysis File, evaluations related to the processes carried out within the company are not sufficient. The raw material procurement process, production, storage, transfer, sale and usage characteristics of the medical product should also be mastered.

ISO 13485 and Risk Management

The ISO 13485 standard requires medical device manufacturers to integrate risk management while establishing quality management systems. Risk management is the systematic assessment and minimization of all potential risks that may arise during the design, manufacturing, distribution and use of devices. The aim of risk management is to ensure that the device is safe and effective.

ISO 13485 recommends that manufacturers follow the following steps to effectively manage risks:

1. Develop a Risk Management Plan

Producers should implement risk management processes within a plan. This plan ensures that potential risks are identified, assessed and appropriate measures are taken at each stage. The plan should start from the design phase of the device and continue until the after-sales monitoring phase.

2. Risk Identification and Assessment

ISO 13485 emphasizes that risks must be identified and analyzed. This includes identifying potential risks at each stage of the product:

Risks in the design: How the device poses a risk to user errors, technological challenges or material defects.
Production risks: Errors and quality issues in production processes.
Risks of use: Patient harm or misuse that may occur during use of the device.

Risks are usually assessed based on factors such as probability and severity, with the aim of reducing each risk to acceptable levels.

3. Risk Control and Mitigation

Once risks have been identified, risk control strategies should be implemented. These strategies aim to minimize or completely eliminate risks. Some common risk control methods are:

Software security: Preventing bugs in the software of devices from posing risks.
Material selection: Selecting the right materials to reduce potential health risks, such as biocompatibility.
User training: Providing trainings for users to use the device correctly and safely.

4. Continuous Monitoring and Updating

ISO 13485 specifies that risk management plans for medical devices should continue not only during the product design and manufacturing phase but also in the after-sales processes. Continuous monitoring of risk management processes is required to assess the performance of the device during its time in use in the market.

Benefits of Risk Analysis

Effective use of standards and regulations.
Helping to identify risks.
Providing effective guidance in minimizing the identified risks.
Determining how to monitor and analyze the risks of the products after they are placed on the market.

Nanolab Laboratories Group continues to provide services within the scope of Medical Device Analysis.

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