M
Thank you for your reply.
Our software recognizes himself not AF or arrhythmia. it represents only the recorded data and stores this data (ecg, patient information, ...) The doctor may have more access to this data. it's like a patient data management system but with a medical purpose intended.
When we say that the software in the class A (IEC 62304) classified, then we have no measure for risk reduction. there is always the possibility that a failed diagnosis is made because of software errors and this is defined as alarm range. It directly affects the health of the patient but is not a serious deterioration of health. Therefore, we have established as a class B.
Best regards
Our software recognizes himself not AF or arrhythmia. it represents only the recorded data and stores this data (ecg, patient information, ...) The doctor may have more access to this data. it's like a patient data management system but with a medical purpose intended.
When we say that the software in the class A (IEC 62304) classified, then we have no measure for risk reduction. there is always the possibility that a failed diagnosis is made because of software errors and this is defined as alarm range. It directly affects the health of the patient but is not a serious deterioration of health. Therefore, we have established as a class B.
Best regards