Medical & Regulatory Affairs Specialists, LLC
↗Lake Wales, Florida
Medical & Regulatory Affairs Specialists (MRAS) is a woman-owned, nurse-run consulting firm that provides comprehensive regulatory and clinical research services for the medical device industry. Founded in 2011, the firm specializes in assisting clients with global regulatory approvals for both de novo and legacy technologies, with a particular focus on the endovascular and AI-driven diagnostic sectors.
The company is recognized for its expertise in systematic scientific literature reviews, data mining, and statistical analysis. They work closely with client design and development teams to establish objective performance criteria (OPC) and clinical study endpoints, ensuring that scientific content meets the rigorous standards required for FDA and international submissions.
CLASSIFICATION
SIZE & FINANCIALS
Employees:1-50
Revenue:$1M-$5M
Founded:2011
Ownership:private
Status:operating
PIPELINE
Stage:Commercial
Lead Drug Stage:N/A (Service Provider)
Modalities:Medical Devices, Software as Medical Device (SaMD), AI/ML Diagnostics
Active Trials:0
Trial Phases:-
FDA Approvals:0
EMA Approvals:0
CORPORATE STRUCTURE
Parent Company:Renaissance Worldwide Solutions, LLC
Subsidiaries:Failure Event Database Search Engine, LLC (FEDS-Engine)
Key Partnerships:RAIsonance, Inc. (Clinical and Regulatory support for AI/ML diagnostics), High Alert Institute (Philanthropic research arm)
COMPETITION
Position:Niche Player
Competitors:NAMSA, RQM+, Emergo by UL, MCRA
LEADERSHIP
Key Executives:
Allison A. Sakara - President
Mona Kelley - Managing Member
Scientific Founders:Allison Sakara, Mona Kelley
LINKS
Website:medicalregaffairs.com
LinkedIn:LinkedIn Profile
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