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MedTech Summit US
November 5 - 7, 2024
The Royal Sonesta Minneapolis DowntownMinneapolis, Minnesota

Bunty Kundnani
Head of Regulatory Affairs at


Bunty Kundnani is a regulatory science enthusiast passionate about promoting and protecting public health. He learned about the innovative medical technologies and regulatory pathways for global market access during his time at top global MedTech companies, a regulatory body, and a consulting organization. He then decided to apply this decade-long learning at which is a leading global AI company developing software medical devices. His work has earned - 3 US FDA clearances for medical imaging AI and CE MDR certification for 60 AI algorithms from a notified body. In 2022, Bunty was invited by British High Commission to the UK as an expert in AI to harmonize the AI regulations for medical devices between UK MHRA and Indian CDSCO.

He consults two of the big three management consulting firms on global medical device regulations. He is a strong advocate of quality and standards and speaks at various events including those hosted by the American Society of Quality. Bunty has a bachelor’s degree in Pharmacy and a master’s degree in marketing management from Jamnalal Bajaj institute of Management Studies.

Agenda Sessions

  • Navigating the Web: SaMDs, AI/ML and the Regulation Spectrum