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Showing results for:

Dhriti Roy

Vice President, Regulatory Transformation

Articles

Dhriti Roy

Jul 14, 2023

How to Deal With Data Strategy Complexity at the Development Stage for Software as a medical device (SaMD)

Impact of IEC 623O4 and IEC 623O4–1 regulations on AI-based medical software

Regulatory Operations

Dhriti Roy

Jul 14, 2023

MDCG guidelines on the Periodic Safety Update Report (PSUR) - How can IVD Manufacturers Benefit

MDCG guidelines on the Periodic Safety Update Report (PSUR)_ How can IVD Manufacturers Benefit

EU

Regulatory Operations