Founder and Principal Consultant
Statera Regulatory Consulting, LLC
Crownsville, Maryland, United States
Melissa Hall, MSc. is the Founder and Principal Consultant at Statera Regulatory Consulting, LLC. She is a seasoned medical device regulatory expert with over 10 years experience at the FDA. She has held various roles in the agency including lead reviewer, assistant director, consumer safety officer, and policy analyst. Her review expertise ranges across all premarket submission types, with a specific focus in the orthopedic device space. As a consumer safety officer she served as an industry educator of the premarket regulatory processes, and as a policy analyst, she served as a regulatory expert addressing complex regulatory issues and ensuring laws, regulations, and guidances were applied consistently across the center. Now serving as a consultant, she continues her dedication to advancing public health by assisting the medical device community in their efforts to navigate the complex regulatory process and strategy that best aligns with their business goals.
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