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Your device is not covered in the MDCG 2019-11
Not a MDSW

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)
COVERED

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.
NOT COVERED
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.
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