Risk management

Risk management is not only important while engineering and producing a product. 
Also it can improve considerably your error management (CAPA) and your project management.

With a professional risk management you enable identifying of risks and you are able to take appropiate measures to reduce them.

Also you save time and money.


We advise you competently in risk analysis according EN ISO 14971 an in the establishment of relevant processes. With a conform risk management system  you will identify potential risks and you will able to initiate respective mitigation.

But risk management is not only a questions of management, it also means responsibility.

Checking the product is equally important like the quality control as a base for a possible source of error.


Also you have to consider carefully all possible consequences of a decision in different phases of the product engineering.

On request we take care on the following tasks:

  • Implementation of Risk Management Process System
  • operetional implementation of risk analyses
  • moderation of risk management teams
  • monitoring of risk management - activities and reviews as external experts
  • Documentation and tracebility


 Please convince yourself of our expertise: medizintechnik@andreasstrauss.de

We are looking forward to your inquiry.