At Skin Analytics we have found that part of the skill required to successfully develop AI as a medical device is to know when to ask for help. Recently we undertook a project to develop a back end for our AI solution. We needed more than something that just worked, we also had to ensure that we are able to meet the regulatory requirements for us to deliver our service.
That meant searching high and low for a uniquely skilled partner. Eventually we happened across Pro4People, a company specialising in developing software that is compliant with IEC 62304. What is IEC 62304??? At the risk of over simplifying it, IEC 62304 details the life cycle requirements for the development medical device software.
Pro4People have written a case study that beautifully describes the work that we undertook together. If you are interested in knowing how seriously we take our regulatory responsibilities I highly recommend that you have a read.