CE Marking applications, EU device registrations and establishing new quality systems for medical device manufacturers are Marcus Gould specialties.
Marcus Gould – Contact information:
Education & Work Experience:
Marcus has experience submitting and obtaining CE Marking approval for a range of medical devices–Class IIa, Class IIb and Class III. Devices range in complexity and technology. For example: 1) advanced infusion pumps and associated administration sets, 2) implantable glucose sensors, and 3) in vitro diagnostic (IVD) devices.
Marcus worked for a number of start-up device companies and established multi-national companies encompassing all aspects of CE mark activities. Marcus’ experience includes both pre-market and post-market activities. He devises and implements regulatory strategies for CE Marking applications and he has a great deal of experience interacting with different EU Notified Bodies and competent authorities.
Marcus Gould – Educational Background
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’.
Marcus Gould – Specialties
Marcus specializes in pre-market CE Marking applications and registration of medical devices in the EU. He also has extensive expert knowledge with regard to post-market interactions with Notified Bodies and Competent Authorities regarding vigilance reporting of adverse events.