Risk Management

There are 2 main risk approaches to focus on for the medical device quality management system.

1) “Product Risk Management” to be carried out in accordance with EN ISO 14971:2012 standard to fulfill the safety and performance requirements of medical device
2) Risk Management of Quality Management System

You can get support from the expert team of AdviQual in performing Risk Analysis for both processes.

Product Risk management ensures that products and production processes are safe and effective.

Risk management is a continous process that should be alive throughout life cycle of medical device. Therefore, it covers all life cyles of the product such as design, usage, production and monitoring post-production risks.

So you should keep the risk management file of the medical devices up-to-date throught the life of the product.

EN ISO 14971:2012 puts in order risk management steps as risk identification, risk assessment, risk reduction as far as possible.  
Risk consists of two component parts.

  • Probability and
  • Severity

The next step following the risk assessment stage is to control this generated risk. Risk control focuses on eliminating the hazards. If it can not be eliminated, the focus is on preventing or detecting events that lead to a hazardous situation. Checking the validity and effectiveness of each risk control can be achieved through validation studies which require engineering knowledge.

The possibility of damage should be re-evaluated after the risk control measurements are applied. It is required to check the effectiveness of the applied risk control and to verify that the risk control is being implemented in order to assess these remaining risks. 

Risk analysis report shows that the risk management plan is applied with the information collected by using the appropriate methods from design, usage, production, and post-production, the acceptability of the residual risks and the risk-benefit analysis is performed. 


Risk Management