ISO 14971 Risk Analysis For Medical Devices

There is a saying, “A bitter pill to swallow”, which means that we have to accept it even though it is very unpleasant. Similar way, the products which we are used for the treatment of patients have some side effects or harm, but we should use them to save lives.

Then how can we proceed further?

Let’s come to know that there is a probability of occurrence of harm associated with the use of particular medicine or device. We should estimate the severity of that harm. We generally called it “Risk”.

There are different levels of severities for different types of harms for a particular medical device, based on its intended use. It means there are different levels of risks associated with a device, and we should estimate each risk for its acceptability to use on humans.

How can we determine the acceptability of risks?

Medical devices are developed for particular medical purposes, which means they have certain benefits. So, we should compare the help with the risks to determine the acceptability of risks of a particular medical device.

Are all the risks need to be considered?

Not all the risks need to be analysed, some risks are mitigated by following some processes and procedures, but some risks still are there; even though we applied all the possible measures, these risks, called residual risks, need to be addressed and should be analysed against with the benefits. The benefits must outweigh the risks; then, only the product is acceptable to use. The manufacturer should give assurance about the safety of a medical device, if it has some residual risks, through the benefit-risk analysis process.

Requirements for ISO 14971 Benefit-Risk Analysis

The following are mainly considered for Risk-Benefit analysis,

  • Biocompatibility data
  • Clinical data of similar devices
  • Post Marketing Surveillance data

Benefit-Risk Analysis’ Importance:

During the design and development phase of a medical device, benefit-risk analysis allows us to determine the severity of the risks connected with it. The producer can alter the design, change the materials, or add extra controls to ensure that the product is safe to use. The benefit-risk analysis should be included in the risk management file and assessed during CE Marking and FDA filings in the United States. The medical device risk management file was created following ISO 14971.

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