Background

The University of Nottingham and Tioga Ltd secured Innovate UK grant funding to assemble a joint clinical, design and engineering project team to integrate the an optical sensor into a single use newborn hat and to undertake clinical studies on newborn babies. The hat will enable clinicians to resuscitate ‘hands-free’, reduce delays and errors, and so improve resuscitation outcomes, giving newborn babies the best start to life.

CHEATA are an integral part of the project team and have provided regulatory advice and support as the device progresses towards CE mark readiness and MHRA submission for a clinical trial. From this collaboration, a company, SurePulse Medical Ltd has been established to further develop, test and commercialise the Surepulse device. For more information visit www.surepulsemedical.co.uk.

The CHEATA Solution

The client engaged with CHEATA to undertake the following work

  • To provide advice on the regulatory requirements for the Surepulse device including assessment of progressive iterations of the device and of the technical file for CE mark submission
  • To engage with the MHRA to secure approval for a non-CE marked device to be used in a clinical trial
  • To review the clinical trial protocol to ensure all endpoints required for the CE mark submission are included
  • To attend a Notified Body audit for CE mark submission

Outcome

The project team has secured approval from the MHRA to conduct the clinical trial with a non-CE marked device. Once the trial has been completed CHEATA will continue to work with the project team to complete and assess the technical file and to advise on the submission to a Notified Body for CE mark approval.

 

To find out more about Surepulse Medical Lts, please visit their website - click here

Logo Surepulse