Instructions for use
Feeling Safer
Feeling Safer fulfils the provisions of the United Kingdom Medical Devices Regulations 2002 (UK MDR 2002), where applicable for clinical investigations of UKCA marked medical devices.
Feeling Safer has been designed, developed and tested according to:
ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes.
BS EN 62304:2006+A1:2015 Medical device software - Software lifecycle processes
BS EN ISO 14971:2019 Medical Devices - Application of risk management to medical devices.
DCB0129:2018 Application of clinical safety risk management to the manufacture of health IT systems (NHS and social care standard).
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UKCA marked as a Class I medical device against the UK Medical Devices Regulations (2002) (as they exist in 2024) via the Medical Devices Directive 93/42/EEC |
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Feeling Safer |
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Version R1 V2.0.0 |
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Please read instructions before use
To be used under the supervision of a qualified clinician |
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University of Oxford, Department of Experimental Psychology, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG |
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Instructions for Use
Feeling Safer R1 V2.0.0
1. Introduction
Feeling Safer is for people attending mental health services, aged 16 or older, who are feeling very worried or concerned that others are trying to harm them. Feeling Safer is designed to help people feel safer, happier, and getting back doing more of the things they want to be doing.
It is an online programme (accessed via a computer, tablet, or smart phone) that is guided by a staff member.
2. Intended Use, Indication, and Intended Performance
Use of Feeling Safer is restricted to participants in the Feeling Safer trial. We recommend that participants aim to complete 2-3 sessions each week. Each session should last around 15-25 minutes. Detailed guidance for users is contained in the application.
Staff members should regularly monitor participant progress using the Feeling Safer Management Portal and schedule contact on a weekly basis.
3. Important safety information
Feeling Safer should only be used under the supervision of an approved staff member.
For any urgent mental or physical health concerns please contact the relevant NHS crisis or emergency services.
4. Technical Specifications
This device fulfils the provisions of the United Kingdom Medical Devices Regulations 2002 (UK MDR 2002).
This software product has been designed, developed and tested according to:
ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes.
BS EN 62304:2006+A1:2015 Medical device software - Software lifecycle processes
BS EN ISO 14971:2019 Medical Devices - Application of risk management to medical devices.
DCB0129:2018 Application of clinical safety risk management to the manufacture of health IT systems (NHS and social care standard).