Risk Management – A complex System

The application of risk management by the medical device manufacturer in practise still creates a lot of problems. It is good to realize that it is the responsibility of the manufacturer to fill in some of the requirements for this process, whereby it is also the manufacturer’s responsibility to show the adequacy of the assumptions made during this process.


The application of risk management following the framework as given in the ISO standard, is an important tool to streamline the discussions and when done appropriately, minimizes the work to be done by the manufacturers to demonstrate the overall safety of its device.

The Process of Risk Management