Stephen Smith

QA/RA Manager

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Stephen joined Medovate in September 2020 and has over 20 years’ experience in quality and regulatory.

Having worked with a wide range of companies such as Bayer Diagnostics, Sphere Medical, TwistDx and more recently CMR Surgical, he has gained experience in a wide range of devices from blood gas analysers and molecular diagnostics to surgical robotics.

Working with both start-up companies as well as multinationals, Stephen has had a broad exposure to various quality and regulatory approaches and has had to adapt to changes in requirements over time by finding solutions that are not only compliant but are also pragmatic and work for the business.

At Medovate he is responsible for managing the quality management system and regulatory strategies by ensuring they comply and the products meet clinical needs.

Stephen holds a Bachelors and Masters degree in Geography from the University of Canterbury in New Zealand, a Masters in Medical Diagnostics and a PhD in Quality Management from Cranfield University. He is also a fellow of the Chartered Quality Institute (CQI) and a member of the CQI’s content advisory panel.