Your device is not covered in the MDCG 2019-11

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)

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)

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.