Personal Information
Organization / Workplace
Greater St. Louis Area United States
Occupation
Senior Regulatory and Quality Consultant (Contractor)
Industry
Government / Military
About
Services offered to FDA regulated businesses include regulatory guidance on 510(k), IDE and PMA submissions. Also planning, creating, and auditing quality systems to USA and international standards. Creation of clinical plans including protocol development, case report form development, implementing and managing clinical trials. Also, assistance with Design Control to meet FDA requirements and representing clients in FDA meetings. A professional public speaker who can train persons on all aspects of FDA requirements, and practical and successful solutions to FDA problems.
Contact Details
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