With a year to go on the Sonopill programme, we're thinking ahead to ensuring the results are packaged and ready for taking the outputs to the next stage. This involves planning for first-in-human trials. As devices in human trials are as subject to the European Medical Device Directive (MDD) as those on commercial sale, this means appropriate documentation and the rigour of a Quality Management System like ISO 13485.

To this end a Quality Team has been put together comprising, Dr Christina Lemke, Dr Rachael McPhillips and Dr Richard Mosses. All of them have experience with quality systems in industry, including those relating to medical devices. The team has begun setting up a quality framework.

First published: 20 October 2017

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