Tammy Karikari
Software lead MHRA
Tammy Karikari is a Software Lead at the Medicines and Healthcare products Regulatory Agency (MHRA), where she works at the intersection of healthcare, regulation and technology to ensure software and AI-powered medical devices meet the highest standards of safety, performance and compliance. With a strong background in pharmaceutical regulation and expertise in Software as a Medical Device (SaMD), Tammy combines regulatory insight with technical knowledge spanning software engineering, machine learning, data science, cybersecurity and generative AI. Passionate about advancing medical device innovation, she contributes to policy development, mentors future professionals, and supports the responsible adoption of emerging technologies that protect and improve public health.
Seminars
- Understanding common PMS and reporting challenges for SaMD by examining why organisations fail to recognise reportable events, struggle with adverse event identification and underutilise post-market data
- Exploring emerging challenges in AI-enabled products, including lessons learned from AI Airlock initiatives, dataset limitations and the implications of deploying AI systems in real-world healthcare environments
- Integrating cybersecurity into PMS frameworks by treating cyber incidents and security breaches as part of ongoing post-market surveillance activities to improve risk management and regulatory compliance
