MDR Expert Session

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Gain clarity about the qualifi­cation of your medical device and certainty for planning further develop­ment and marketing

In a one-hour consultation, our expert team will clarify whether your device is considered a medical device and which regulatory require­ments you need to fulfill.

Protect yourself as a manu­fac­turer of medical devices from costly mistakes and reputational damage at an early stage

For medical device manufacturers, the regu­la­tory landscape has become confusing, which unfortunately can regularly lead to serious mistakes: 
​​​​​​​

  1. It is realized too late that the device must meet the MDR's requirements.
    Necessary resources and activities are not planned, which throws budgets and sche­dules out of kilter. In the worst-case scena­rio, customer deadlines cannot be met, or the business case will no longer be profi­table. 
     
  2. It is mistakenly assumed that the device falls under the MDR's requirements.
    The company goes to unnecessary expense or even decides against developing or mar­keting its device or procedure, thereby missing out on opportunities. 
     
  3. It is mistakenly assumed that the device does not fall under ​​​​the MDR's require­ments.
    ​​​​​​​The company exposes itself to risks under civil and criminal law. There is a high pro­ba­bility of warning letters from competitors. The potential financial and reputational damage is significant.
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Our expert team will provide you with clear and reliable answers to the crucial questions in the shortest possible time

In a one-hour consultation, our experts will give you precise answers with ​​​​a stringent line of reasoning to the following questions, for example:

  • Is my device a medical device?
  • Does the device have to fulfill the MDR requirements?  
  • Is my software a medical device software (MDSW)?
  • Does the software fall under the MDR or IVDR requirements? 
  • Does my device require CE marking?   

The expert session also lays the foundation for complex questions. You will receive specific tips on meeting the regulatory requirements with­out unnecessary effort.   

We can also provide you with a written state­ment upon request. 

Contact us now to make an appointment for your expert session.

Contact us, we're happy to help!
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