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MedTech Summit
16 - 20 June 2025
MOA BerlinBerlin, Germany

Bunty Kundnani
Head of Regulatory Affairs at Qure.ai
Speaker

Profile

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 Qure.ai which is a leading global AI company developing software medical devices. His work has earned Qure.ai - 13 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

  • Regulating AI/ML: Where Are We Now?

    09:25
  • Ask the Experts – Software and AI for Medical Devices & IVDs

    16:15