A functioning risk management is a mandatory requirement for all medical devices. DIN EN ISO 14971 is assigned to the field of medical technology and regulates risk management for medical devices in the European market. It is recognized among other things in the North American market and also worldwide.
The aim is to minimize risk through conceptual or constructive measures, or - if necessary - appropriate protective measures. If there are residual risks, those affected must be informed or trained by means of appropriate warnings. In principle, however, the following applies: Any residual risks must be justifiable in relation to the intended beneficial effect. The protection of health and safety must be guaranteed to a high degree.
Successful risk management not only deals with the products themselves, but is also necessary for all processes, including for the manufacture and marketing of medical devices.
The risk management process must be documented and an essential part of the technical documentation.
In every company, risks arise during the normal value creation process. Deviations from predefined target values should be recognized and eliminated promptly, as far-reaching consequences could possibly be the result.
We can assist you in all stages of the process, take it over or provide support.
We would be happy to help you make your risk management project a success. Talk to us, our experts will be happy to advise you.