Marcus Gould – Regulatory & Quality Affairs
Throughout his career Marcus has worked for a number of start-up companies and established multi-national companies encompassing all aspects of CE mark, FDA, and global regulations. Marcus has obtained the CE mark for a wide range of medical device types and classifications, up to, and including, Class III systems, and has led, and obtained, IDE submissions within the US.
Marcus’s experience includes both pre-market and post-market activities, and he devises and implements regulatory strategies for CE Marking, US FDA submissions and global registrations.
Marcus has designed, implemented and maintained Quality Management Systems for ISO 9001, ISO 13485, and ISO 15189. Marcus holds a doctorate in biochemistry (microbiology) from the University of Oxford, holds both Chartered Biologist and Chartered Scientist status, and is a consultant editor for TOPRA’s monthly publication ‘Regulatory Rapporteur’.