A
Is internally used diagnostic software considered a medical device under MDR?
Anonymous
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1 comment
5 months ago
Our company has developed three software components related to EEG and ECG biomarkers to support psychiatric treatment decisions:
• A web interface for hospitals and clinics to upload and store patien
Accepted
2 answers
Yes, your software would be considered Software as a Medical Device (SaMD) under the MDR. Even if you are not placing the software itself on the marke