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 Risk Analysis in the Medical Device Industry

ISO14971

Risk

According to ISO14971, the concept of risk combines two variables: the probability of harm and the severity of harm.

For example, if a particular hazardous situation is very likely to cause hasrm and would be very harmfulif it actually occurred, then it would be a high risk situation. Conversley, if it's very unlikely to cause harm and would be only slightly harmful if it actually occurred, then it would be a trivial risk.
 

Risk analysis is a systematic process that is used to identify hazards
and to estimate risk. It includes an examination of every reasonably
foreseeable sequence or combination of events that could produce
a hazardous situation and cause harm.


Risk analysis is a process that is used to identify hazards and to
estimate risk. Risk evaluation is a process that is used to examine
the estimated risk for each hazardous situation and then to use risk
acceptability criteria to determine whether or not the estimated risk
is acceptable and to decide if risk reduction is required. 

Risk management uses management policies, procedures, and practices
to systematically analyze, evaluate, control, and monitor risk. 

 

A risk management file must be created for each medical device.
Your risk management file should include all of the records and
documents that your risk management process generates.

Risk management files should contain risk management plans and
are used to record risk analyses, risk evaluations, risk control measures,
and residual risk evaluations. Risk management files are also used to
facilitate traceability and to check whether or not your organization
complies with this ISO 14971 standard.

Risk control is a process that is used to consider risk control
options and to select and implement risk control measures that
will reduce risk or maintain risk within specified levels. ISO 14971
expects you to consider the following risk control options and,
if possible, to apply them in the following order:

1. Design safety into the product.
2. Establish protective measures.
3. Provide safety information. 

Risk estimation is a process that is used to assign qualitative or
quantitative probability values and severity values to each hazardous
situation. These values are then used to estimate risk.

For example, if a specific hazardous situation is very likely to cause harm
and would be very harmful if it actually occurred, then it would be a high
risk situation. Conversely, if it’s very unlikely to cause harm and would
be only slightly harmful if it actually occurred, then it would be a trivia lrisk.

Of course, this is just a simple example. You can use any
appropriate probability and severity categories.
Risk evaluation is a process that is used to examine the estimated
risk for each hazardous situation and then to use risk acceptability
criteria to determine whether or not the estimated risk is acceptable
and to decide if risk reduction is required.

 

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