Introduction to developing certified software as a medical device

This short video provides an introduction to medical device development – and aims to demystify the process. Watch the guide to find out how to navigate the certification process; from the quality management system through to your device master record, through each of the planning, development and reporting stages.

OCC’s innovation delivery team has delivered Class I, Class IIa, Class IIb UKCA and CE-marked medical devices. In recent years this has included the application of AI to cardiac and foetal ultrasound as well as apps to perform clinical triage and support. We can work to ISO 13485, ISO 14971 and IEC 62304 standards. A selection of these projects are summarised on our website: (

Oxford Computer Consultants is a software development company specialising in health and social care applications. OCC’s custom software team provides bespoke services in Data & AI, Medical Device Development and Mobile apps. In addition, specialists can be hired for consultancy services. Our social care products manage and deliver social services worth £7bn in over 80 Local Authorities.