Medical devices have a major impact on patients’ and users’ health. When these devices aren’t functioning properly or when used incorrectly, serious injuries can occur. Therefore, developers, manufacturers and regulators recognize the importance of risk management for medical devices, since it helps you identify and address safety issues throughout the device life cycle.

So, how can you perform your own risk management? In this blog post we’ll talk about a 6-step process that you can follow for safer medical devices.

Why do you need risk management for medical devices?

Risk management can help you ensure that the medical device functions as expected and causes no harm to the patients. However, risk management in medical devices is also required by regulatory agencies, that expect manufacturers to evaluate and mitigate the risks associated with the product, ensuring device usability and safety.

Thus, it’s crucial to implement risk management practices continuously throughout the product lifecycle. This way you can ensure your medical device is safe for users and you comply with the strict regulatory requirements. 

Therefore, organisations need a robust risk management system to reduce or mitigate the chances of failure in the product.

Now that you understand the importance of managing the risks of your medical device, let’s focus on the risk management process itself!

Getting started with risk management

Similar to ISO 14971:2019, there are many other regulations that specify risk management steps during the development of medical devices. Their approach could be different, but the objective  is the same.

ISO 14971:2019 is the current state-of-the-art for risk management in medical devices. Its purpose is to define a standard that helps manufacturers identify the hazards associated with the medical device, and to estimate, evaluate, control and monitor the risks at all stages of the product life cycle.

According to ISO 14971: 2019, the risk management process includes the following steps:

  1. Risk management planning
  2. Risk assessment (risk analysis and risk evaluation)
  3. Risk control
  4. Evaluation of overall risk acceptability
  5. Risk management report
  6. Production and post-production information

1. Plan your medical devices risk management

This process, as represented in figure 1, should start with a risk management plan. This plan defines the risk management activities you anticipate and plan throughout the product life cycle. Additionally, this plan is designed for a particular device. Therefore, if you manufacture multiple types of devices, your risk management plan needs to be specific to each one.

Figure 1 – Risk management process for medical devices according to ISO 14971:2019

2. Perform the Risk assessment

Once you have your plan established, you can start your risk assessment. ISO 14971:2019 considers risk analysis and risk evaluation as separate tasks that come together as risk assessment. You should begin the risk analysis by identifying the intended use of the medical device, i.e., the purpose of the medical device. This definition will help you in determining the correct use of your device, as well as its misuse. Based on this and on the medical device under normal and fault conditions, identify the hazards associated with the device and the reasonably foreseeable sequences of events that can lead to hazardous situations.

Next, you must evaluate these estimated risks. For this you should use the criteria for risk acceptability defined in the risk management plan and determine if the risk is acceptable or not. Some common tools used to evaluate risks are the Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis, and Hazard Analysis.

3. Control the estimated risks

In case you determined a risk as not acceptable, then it is necessary to perform risk control. The goal in this step is to mitigate or reduce risks to an acceptable level. There are different ways to control a risk, from changing the design of the product, to labelling or add instructions regarding the risks that you couldn’t reduce.

4. Evaluate the overall risk acceptability

When all the individual risks are identified and controlled, you must evaluate the overall residual risk acceptability of the medical device as whole using the same risk evaluation criteria. This step is important because the combination of different small risks can result in a big risk. If the residual risk is not acceptable, you should perform a benefit-risk analysis to determine if the benefits of the medical device outweigh the residual risks.

5. Review your process

Before going to market with your medical device, the ISO 14971: 2019 requires the manufacturer to review the results of all the risk management process to ensure completeness. This report should also include your plans for evaluating risk in production and post-production.

6. Document the production and post-production activities

Risk Management is a product life cycle process and, as such, you should continuously analyse your product in the market. These production and post-production related activities and events need to be documented by medical devices manufacturers and developers.

Deliver safer medical devices with digital QRM

Although the risk management process for medical devices may seem complex, it doesn’t have to be. Implementing a digital QRM can help you assess the risks of your device, making sure you identify all the hazards associated with the product.

Additionally, having only one platform for your entire team can make your risk management throughout the medical device lifecycle easier. This way, you don’t have miscommunication and lost information that could lead to more risks in the final product. Besides, it can also benefit you during the review and document activities phase, since you’d have all the information compiled in one place.

We can support you with your risk management for medical devices

The risk management required for your medical devices might seem complex, but we can help you throughout all the process! With our risk management platform, and 4TE experts, we can help you identify, evaluate and control risks, making sure you deliver the safest medical devices to patients and users.

If you want to know more about our services, check out our page and don’t hesitate to reach out!