Anusha Venkatesan

Anusha Venkatesan is a seasoned regulatory professional with a robust background in SaMD regulatory intelligence, clinical safety reports, and risk management. With a solid foundation in biomedical engineering and health service management, Anusha excels in quality management, complaints handling, vigilance monitoring, and CAPA processes.

Anusha has extensive experience in creating and maintaining Quality Management Systems (QMS), technical files, and design dossiers for SaMD, including the NHS-Covid19 App. Anusha’s expertise in AI regulatory intelligence has led to the development of regulatory, quality, and clinical strategies for AI imaging software in the UK, EU, and USA.

During the pilot phase of the AI-Airlock programme at MHRA, Anusha played a pivotal role as a case manager, identifying regulatory gaps and providing critical findings and recommendations. Anusha’s contributions have been instrumental in ensuring regulatory compliance and advancing the field of medical device regulations.