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  • Writer's pictureEmmanuel Arenas Urrea

The importance of the risk-based approach in medical device manufacturing.

A risk-based approach is a methodical approach that contemplates risks in order to try to foresee them as an independent element of the Quality Management System, taking into account that risk is inseparable from any aspect related to it, understanding that risks are present in all processes, systems or functions.

The relevance of this approach lies in the interaction between the medical device and the patient or user of it, understanding as a user the personnel who use the device and as a patient the person who will be treated/diagnosed with it. This interaction can have such severe repercussions that it can cause injuries or even death to both users and patients.

Because risks are inherent in any process related to the device life cycle, from design to commercialization, this approach allows us to treat risk as proactive rather than reactive, preventing or decreasing the unwanted effects of risk by identifying and controlling them in advance.

The proper approach to diminish or foresee the undesired effects of the risks inherent to the life cycle is related to foreseeing both the probability of occurrence and the severity of these, where the intention of use of the device conditions the benefits and the risks involved in its handling, ensuring that it is more beneficial with respect to the possible damage caused, the intention of use will determine the benefit in contrast to the risk of this.

This is where the concept of Risk Management is used, based on the intended use of the device, defined as the systematic application of policies, procedures, and management practices to the tasks of analysis, evaluation, control, and monitoring of risk, comprised by:

  • Risk Analysis: Identification and estimation of risk through the systematic use of available information such as Intention of Use and characteristics related to the safety of the medical device.

  • Risk Assessment: The process of comparing the estimated risks against a given risk criterion to determine the acceptability of the risk.

  • Risk Control: Process in which decisions are made and measures are implemented by which risks are reduced or maintained within specified levels.

  • Evaluation of the overall acceptability of the residual risk: Process in which decisions are made regarding the remaining risks after Risk Control measures have been taken, which may result in new Risk Control actions.

It should be noted that the risk management process is an activity that accompanies the medical device throughout its life cycle, so prior to its commercialization it is necessary to demonstrate that it has been properly performed through the Risk Management Report, a document that ensures that the Risk Management Plan has been properly implemented, that the overall residual risks are acceptable and finally that there are adequate methods to obtain relevant information on production and post-production.

Now that you know the importance of the risk-based approach in the design and development of medical devices, we can help you create a risk management system based on this approach to improve your processes, contact us.

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