Release R1 [Version 00.00.01]
Instructions before use
Refer to instructions for use for instructions before use
eWellness Ltd at PO 976, Richmond Upon Thames, TW9 9JH
This device fulfils the provisions of the European Commission (EC) Directive 93/42/EEC ( Medical Devices Directive).
This software product has been design according to:
Medical devices - Quality management system - Requirements for regulatory purposes
Clinical Risk Management: its Application in the Manufacture of Health IT Systems
Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems
ICE 62304:2006 Amd 1:2015
Medical device software - Software lifecycle processes.
This device has been developed under the strict quality system of eWellness Ltd.