Chief Counsel FDA and Healthcare Regulatory Compliance
Siemens Healthineers
Monika Bhatt, LL.M, RAC
Chief FDA and Healthcare Regulatory Compliance Counsel at Siemens Healthineers North America
Monika Bhatt has over 20 years of experience advising clients on a broad range of regulatory and business matters guiding her clients through U.S. Food and Drug Administration (FDA) regulations, requirements, and compliance issues, including premarket notification, premarket approval, Medical Device Reporting (MDR), product recalls, Quality System Regulation (QSR) compliance, establishment registration and device listing, labeling and promotion, import/export issues, clinical trial requirements, complex due diligence regarding FDA compliance status, and FDA inspections and enforcement actions.
Having represented both large multinational corporations and small startups on corporate and transactional matters, government enforcement investigations, compliance program design and implementation, she has a broad knowledge of regulatory and business issues impacting health and life sciences companies. Monika has written and spoken extensively on various aspects of FDA regulation of medical devices.
Disclosure information not submitted.
Monday, September 12, 2022
2:00 PM – 3:00 PM MST