As the Co-Founder of Deviceology Ltd and an established authority in regulatory affairs, international standards, and market access strategies for medical devices, including Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD), I bring over a quarter-century of experience to these complex and evolving sectors.

Throughout my career I have acquired extensive expertise in Medical Device Regulations and Market Access. This is underpinned by my multi-disciplinary experience in Information and Cyber Security, along with a strong focus on the rapidly evolving field of Artificial Intelligence within healthcare. My expertise in compliance is extensive, covering key international standards such as ISO 27001, ISO 13485, and ISO 14791. Additionally, I possess in-depth knowledge of diverse regulatory frameworks, including the UK MDR, EU MDR, ANVISA in Brazil, TGA in Australia, FDA regulation in the U.S., and Canadian regulations.

My current focus is the complex landscape of AI Regulation, particularly its incorporation into Medical Devices across various healthcare sectors in the UK, US, Brazil, Canada, the EU, and Japan. This includes a commitment to understanding and shaping the ethical and practical dimensions of Artificial General Intelligence (AGI), as we move quickly towards realising it, and its anticipated impact on the development and use of medical devices.

At Deviceology, we are dedicated to devising and implementing robust regulatory and commercialisation strategies for clients aiming to penetrate markets in the UK, US, Brazil, Canada, the EU, and Japan.

My skill set includes:

- Standards Compliance: Expertise in ISO 27001, ISO 27701, ISO 13485, ISO 14791, and ISO 42001.

- Regulatory Compliance: Expertise in UK MDR, EU MDR, U.S. FDA, ANVISA, TGA, and MDSAP.

- Artificial Intelligence: Growing expertise in AI Ethics, AI Governance, AI Regulations, Machine Learning Algorithms, and Natural Language Processing.

- Data Privacy: In-depth knowledge in GDPR, HIPAA, LGPD (Brazil), and APP (Australia).