Workshop: Risikomanagement nach DIN EN ISO 14971

Most international medical device regulations require manufacturers to implement risk management activities along the medical devices product lifecycle. 

However, many companies struggle with product lifecycle definition and implementation of suitable activities. 

This workshop is intended to provide a model of a product lifecycle - respectively design process activities and postmarket activities - and to show the various forms of risk management activities therein. 

For most of the risk management activities examples are given and the concept of risk based thinking in decision making or solution finding is introduced. 

Individual risk identification and evaluation methods are shown on a high level.