Risk Management Analysis (ISO 14971:2019)
Medical Device Manufacturers have a legal obligation to regularly maintain and perform risk management analyses. ISO 14971:2019 helps the manufacturer standardise their Risk Management practices.
Do you know what the purpose of ISO 14971:2019 is?
ISO 14971:2019 is the international standard for risk management in medical devices companies. It is a 9-part document that establishes risk analysis, evaluation, control, and management guidance. This document also specifies procedures for review and monitoring during production.
ISO 14971 is an international standard that is recognised universally; the following governments recognise this standard:
- The U.S. Food and Drug Administration (FDA)
- The EU has harmonised with the European Medical Devices Directive 93/42/EEC.
- Australia TGA (Therapeutic Goods Administration)
- Japan MHLW (Ministry of Health, Labour, and Welfare)
Wondering how to conduct Risk Analysis for Medical Devices?
The ISO 14971 standard outlines a process for identifying the potential risks associated with medical devices. It helps ensure the safety of a medical device during the product life cycle. The process steps are:
- Risk management framework and planning
- Risk analysis
- Risk evaluation
- Risk control
- Reports and documents
- Any risk management process must be defined within a risk management framework to comply with regulations like FDA or ISO. The framework describes the process for developing the device and the roles and responsibilities of people involved in the device development process. It is also essential to establish proper documentation of the risk management plan.
- Risk analysis will help manufacturers of medical devices define the intended use of their products and take appropriate risk management measures. During this stage, it is crucial to identify foreseeable hazards as early as possible to assess risk.
- Calculating and evaluating risk involves identifying the severity and occurrence (probability) of risks. The decision about which hazard needs to be addressed first can be based on the visualisation of the risk matrix based on a hazardous situation (highly likely to occur) but with low harmful effects.
- As soon as a risk is identified, the next step is to control the risk. This is when risk mitigation is implemented. Managing risk means lowering the intensity of risk to an acceptable level. There are several ways to do this:
- In some cases, it may be possible to mitigate the risk by changing the product design, but that is not always possible.
- The next option is to incorporate protective measures that fit the risk and decrease the chance of harm.
- Last option is to add instructions in the device manual regarding the risks involved in the device.
The final step in the process is to document the risk management plan and strategies. The document must contain all the actions, assessments, and reports created during the risk management planning process.
Despite following all these processes, manufacturers at times face difficulty justifying various regulatory aspects of Medical Innovation.
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