Device Compliance
The pulse acquisition device we deploy is a product holding a Class II medical-device registration certificate; the doctor-assistive software is scoped separately and the two are never claimed as one.
Hardware: pulse acquisition device
The pulse acquisition device we deploy is a product holding a Class II medical-device registration certificate. At procurement we verify and retain the registration certificate, instructions for use and certificate of conformity.
The device is used within the intended use approved on the certificate; public statements are kept consistent with the instructions for use and labelling, and this site makes no efficacy claims beyond that scope.
Software: functional boundary
The doctor-assistive software is used only inside the internet hospital, by doctors, to retrieve and organise records. Its functional boundary is assistive inquiry, case structuring and aggregation of prior records.
Syndrome conclusions, treatment-method selection and prescriptions are made by licensed doctors, who remain responsible for them. The software is not claimed as a medical device and does not replace clinical judgement.
Management in use
- 01Procurement & acceptanceRegistration certificates, instructions for use and conformity certificates verified per batch and retained.
- 02Adverse eventsCollected, evaluated and reported to the registrant and regulators as required.
- 03Calibration & maintenanceDevice batches, calibration and maintenance records are logged and auditable.
- 04Operator trainingAcquisition staff at partner sites must complete device-operation and hygiene training.