mOm granted CE mark for first incubator product Leave a comment
mOm Incubators’ first product – the mOm Essential Incubator – has been granted regulatory approval with the CE mark.
First deployments of the lightweight Incubator, created by mOm founder & CEO, James Roberts, and developed by mOm & the engineering team at eg technology, are to commence in the NHS as part of a series of pilots to help reduce the need for short-term admission to Special Care and to help maintain the core temperature of babies being moved around hospital sites.
mOm is also working with outside partners on the deployment of the mOm Essential Incubator overseas.
The mOm Essential Incubator is designed and approved to be used across a variety of settings and can run off multiple power sources to vastly increase the opportunities for vital care to be administered.
eg technology undertook the entire end-to-end development of the incubator, from initial concept to transfer to manufacture. We were able to provide mOm with a fully integrated engineering resource, across software, electronics, mechanical engineering and industrial design, working to a clearly defined, phased development programme to meet the clinical and business goals of the client. As with all medical device development, safety and efficacy were central to the programme and eg technology engineers were able to use their expertise to ensure that the product was developed in accordance with IEC 60601, IEC 62304, ISO 14971, all within eg’s own ISO 13485 quality management system.
James Roberts, CEO & founder of mOm, said: “It has been an incredible journey turning a university project into a fully approved and regulated medical device that is now helping to sustain life in the NHS. The original inspiration was built on the idea of giving clinicians a more flexible solution that can expand access to neonatal care. I am thrilled and humbled that we are able to help in the UK now and overseas in the near future.’
eg director and co-founder Andrew Ede added: “We would like to extend our congratulations to James and his team at mOm. It has been a privilege to be part of this pioneering project. The regulations around incubator development are, quite rightly, stringent, so to develop a product which met the exacting regulations both from the point of view of device safety and ISO 60601, as well as medical device software to IEC 62304 Class C, and to now achieve CE Marking is testament to the skill of our engineers.”
