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In 2012, Professor Dean Barratt created the UCL QMS, a medical software related quality management system (QMS) to accelerate the clinical translation and commercialisation of advance image analysis techniques. For over nine years the QMS has been certified by the British Standards Institute (BSI) and has continued to evolve.
Sarina Hussain - Quality Manager (BSc, MSc, CSi)
Sarina has worked within medical device quality for over seven years, she has worked in many different areas of industry including IVD manufacture and diagnostic development. Sarina has experience of managing a variety of different medical device products ranging from Class I to Class III and is a BSi certified internal auditor in the medical device quality management standard ISO 13485. Sarina will be the first point of call for any regulatory and quality questions, support or issues.
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Professor Dean Barratt (PhD, MIPEM)
Dean is Professor of Medical Image Computing at UCL. His research encompasses the development, evaluation, and clinical translation of software-based medical devices, with a focus on computer-assisted surgery and cancer diagnosis using AI technologies. Dean led the development and commercialisation of SmartTarget, CE-marked, FDA-approved software for guiding tumour-targeted prostate cancer biopsy and treatment. This technology has been used in over 1,200 patient procedures to date, and is now the basis of the Focalyx Fusion system marketed by Intuitive Fusion LLC. Dean is a member of the MHRA Artificial Intelligence, Software and Apps Expert Advisory Group, and is the Management Representative of the UCL/WEISS Medical Device QMS.
Sam Shelley - Quality and Regulatory Consultant
Samantha Shelley, Shelley Quality Management Services (SQMS) Ltd. has over 25 years of experience in medical device quality management system and regulatory compliance covering products from Class I to Class III.