James is a highly experienced regulatory and quality specialist with over 20 years in the medical device industry, spanning Quality, Regulatory Affairs, Design Assurance, and Device Development. His expertise covers EU MDD, EU MDR, and UK MDR, with a strong working knowledge of EU IVDD, IVDR, and FDA Quality System Regulations. 

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He has supported a wide range of device manufacturers across multiple therapeutic areas, including ophthalmic, perinatal, neurological, rehabilitation, and implantable devices for cranio-maxillofacial and orthopaedic applications. This breadth of experience gives him a practical understanding of the challenges manufacturers face at different stages of the product lifecycle. 

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James provides strategic regulatory guidance to support market access in the EU, UK, and US. His work includes conducting gap assessments against EU MDR and ISO 13485, developing regulatory strategies, and supporting their implementation. He is also highly experienced in the development and remediation of technical documentation, ensuring it meets current regulatory expectations and stands up to scrutiny. 

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His technical writing expertise spans usability, risk management, post-market surveillance, device classification, applicable standards, GSPRs, and compliance documentation. He also supports the development of quality management system procedures and has experience with UK device registrations via MHRA DORS. 

James holds a PhD in Organic Chemistry, an MSc in Analytical Chemistry and Instrumentation, and a BSc in Chemistry and Physical Education and Sports Science.