Regulatory Strategy

A tailor-made regula­tory strategy as basis for your success­ful market access

Our experienced experts will work with you to develop a regula­tory strategy tailored to your needs and require­ments.

We proceed as follows:

1. Our team will first gain an overview of your situation and get to know your device and project in detail. 
    
2. Our regulatory affairs experts then start with detailed research into relevant sources of informa­tion to:
    ​​​​​​​
   • qualify your device, 
   • formulate your intended purpose or adapt the existing one, if necessary, 
   • classify your device according to the rules in the target country, 
   • select the appropriate approval procedure, 
   • identify applicable device-specific regula­tory require­ments such as standards, common specifications, or guidelines, 
   • determine the require­ments for the QM system, and 
   • derive the country-specific require­ments for the necessary documen­tation. 
      
3. If you want to market your device outside Europe or launch it in several markets at the same time, our team will also be happy to analyze: 
   ​​​​​​​
   • in which order you should bring your devices to which market, 
   • whether combined registrations are possible,  
   • which local partners can support you with registration, and 
   • which authority you can interact with and how. 
      
4. Our clinical affairs team can also take care of your clinical strategy​​​​​​​ on request. 
   ​​​​​​​​​​​
5. Finally, you will receive a detailed report with recommen­dations for your regulatory strategy, the calculated duration and costs for your device approval, infor­mation on possible risks, and suitable minimi­zation measures.