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Invitation Only
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Separate Ticket or Advanced Registration Required
Repeat Solutions Circle
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Monika Bhatt

Chief FDA Regulatory Healthcare Compliance Counsel
Siemens Healthineers

Monika Bhatt has over 20 years of legal experience advising clients on a broad range of FDA regulatory healthcare compliance and other business matters, including market access, pre-market strategy, post-market compliance, Medical Device Reporting (MDR), product recalls, Quality System Regulations (QSR), establishment registration and device listing, labeling and promotion, import/export compliance, clinical trials, M&A Regulatory due diligence, 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 science companies. Monika has written and spoken extensively on various aspects of FDA regulation. She is Regulatory Affairs Certified (RAC) and Healthcare Compliance Certified.

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