Darshita Chauhan

Regulatory Affairs professional with a Master's in Regulatory Affairs and a Bachelor's degree in Microbiology. Knowledge of ISO 13485:2016, CAPA, and USFDA requirements. Skilled in regulatory compliance, audits, and submission preparation. Certified in Internal Auditor for ISO 13485:2016, Good Clinical Practice and Medical and Food Microbiology. Committed to ensuring quality assurance and compliance with GxP standards.

AI-Enhanced SaMD : Regulatory Compliance, Market Analysis, and Submission Pathway Development

• Supported the Medic Copilot project, leveraging AI technologies to enhance medical care in challenging environments.
• Conducted research on Software as a Medical Device (SaMD) for diagnostics, ensuring regulatory compliance and product development.
• Collaborated on defining software features and user interface elements to optimize diagnostic recommendations.
• Conducted market surveys and analyzed approval processes for Medic Copilot in comparison to USFDA-approved SaMD.
• Provided expertise on AI algorithms for diagnostic recommendations and contributed to submission pathway development.
• Managed documentation drafting and refinement for regulatory approval, ensuring compliance and professionalism.
• Overcame challenges in device classification and regulatory pathway identification through research and adaptive strategies.

Northeastern University - Toronto

Master of Science (M.S) - Regulatory Affairs 

 Major - Majors: Drugs, Biologics & Medice device