Your device is not covered in the MDCG 2019-11

 
Fish
What does this mean for the development effort? Please contact us to find out.

Contact us for a free sample report.

Disclaimer

The Classification of Medical Devices according to MDR can be ambiguous. 

Xybel is not responsible for erroneous classification - either due to user-based or a tool-based error.

Please contact us for a detailed analysis.

Your Software is covered by the Medical Devices Regulations (MDR/IVDR)

 
Avocado
What does this mean for the development effort? Please contact us to find out.
 
Contact us for a free sample report.

Disclaimer

The Classification of Medical Devices according to MDR can be ambiguous. 

Xybel is not responsible for erroneous classification - either due to user-based or a tool-based error.

Please contact us for a detailed analysis.

 

Your Software is not covered by the Medical Devices Regulations (MDR/IVDR)

Spicy Peppers
What does this mean for the development effort? Please contact us to find out.
 
 
Contact us for a free sample report.

Disclaimer

The Classification of Medical Devices according to MDR can be ambiguous. 

Xybel is not responsible for erroneous classification - either due to user-based or a tool-based error.

Please contact us for a detailed analysis.