AI Compliance in Pharma: EU, US & UK Legislative Insights
Ipshita Chattopadhyaya
24 Jun, 2025
Dr. Ipshita Chattopadhyaya is a regulatory affairs expert with over eight years of experience, specializing in medical devices. She has extensive expertise in clinical evaluation and compliance with EU MDR 2017/745, covering a range of therapeutic areas, including ophthalmology, orthopedics, and hematology.
At Celegence, she leads the development and review of high-quality regulatory documents, ensuring compliance with MEDDEV 2.7/1 Rev. 4 and MDR requirements. She is also experienced in systematic literature reviews, risk management, and post-market surveillance.
Dr. Chattopadhyaya holds a Ph.D. in Pharmaceutical Sciences and has authored scientific publications in leading journals. Her regulatory knowledge and industry experience enable her to provide strategic guidance on medical device compliance and regulatory submissions.
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