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Clinical Safety
Clinical Safety of SingFit
The clinical safety of our products is of paramount importance to us at SingFit. Based on the UK’s National Health Service (NHS) Digital standard clinical safety requirements, information regarding our safety compliance and risk management measures are outlined below.
DCB0129 and DCB0160 Compliance
Our Clinical Safety Management File contains several documents to comply with DCB0129 and DCB0160 standards:
Clinical Risk Management System - Outlines the processes to be followed to ensure SingFit is developed, implemented, and used in a safe manner.
Clinical Risk Management Plan - Identifies clinical risk management activities to be employed during the development, implementation, and use of SingFit.
Clinical Safety Case Report - Describes SingFit’s clinical safety processes and assurances.
Hazard Log - Describes SingFit’s clinical safety processes and assurances.
Clinical Safety Officer
The CSO is responsible for clinical safety of the SingFit, through the application of clinical risk management procedures. SingFit’s NHS digitally trained Clinical Safety Officer is:
Dr. Jennifer Myers, CCC-SLP
Senior Product Manager
Licensed and Certified Speech-Language Pathologist, MD #06978
Digital Technology Assessment Criteria (DTAC)
DTAC is a UK(England)-only grouping of assessment criteria which incorporates the DCB0129 and DCB0160 standards for clinical safety. At this time, SingFit is in the process of becoming DTAC-certified and will provide the appropriate documentation once completed.