The new MDR (Medical Device Regulation) is here. And with it come additional requirements for technical documentation. For example, the following chapters of technical documentation require extensive adjustments:

• General safety and performance requirements
• Clinical evaluation
• Market surveillance

Our experts support you with advice and assistance in the preparation, completion and maintenance of your documents in German and English. We will also show you how you can optimally structure STED, DHR, DMR and DHF in order to minimize the effort required to create and maintain technical documentation.