Intended use

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Exclusively for clinical investigation. The app is intended only for participants registered to take part in the REFUEL-MS trial.

The device fulfils the provisions of the UK MEdical Devices Regulations (2002) as a class 1 software as medical device product.

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Please refer to the instructions for use before using REFUEL-MS www.refuel-ms.com/usermanualhcp

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This software product has been designed according to:

BS EN ISO 14155:2020 - Clinical investigation - good clinical practice

BS EN ISO 13485:2016+A11-2021 - Medical devices - Quality management systems - Requirements for regulatory purposes

BS EN ISO 14971:2019+A11-2021 - Medical devices - Application of risk management to medical devices

DCB0129:2018 - Clinical Risk Management: its Application in the Manufacture of Health IT Sytems

IEC 62304:2006 Amd 1:2015 - Medical device software - Software lifecycle processes

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This device has been developed under the strict quality system of King's College London