Testing of Human Database
The testing of human database test requires the establishment of a large amount of clinical data. CIBDS Lab has defined a rolling clinical evaluation system according to the Software as Medical Device (SaMD) according to the International Medical Device Regulators Forum (IMDRF). Firstly, a model of indications and clinical data is established in the clinical evaluation of the wearable device. The model uses algorithms, inference engines, logic rules, and reference data to make inferences about indications (such as diagnosis) for clinical data. , Inform or treat, etc.), use the model to find new clinical evidence and build or modify the functions of wearable electronic products based on this model, and track the feedback of users after launching to the market and obtain new clinical data. Then invest in data review and supervision, at the same time, accumulate continuous clinical data through this process, it can be used to test the human data database for this wearable smart device testing standard platform. The types of human database currently accumulated are as follows:
(1) Arrhythmia database
(2) Blood pressure database
(3) SpO2 database
(4) Dynamic heart rate database
(5) Sleep database
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