Memphis Regulatory Consulting, LLC
- Memphis, Tennessee, United States
Memphis Regulatory Consulting, LLC Employees
Memphis Regulatory Consulting, LLC Details
Memphis Regulatory Consulting, LLC (MRC) offers a comprehensive solution for your regulatory, quality or clinical consulting needs. We are proud to offer tailored services to meet your project completion or strategic guidance objectives, regardless of company size or budget. Founded in 2009 and based in Memphis, TN, we are centrally located for your convenience. We provide expert services in the following areas: Regulatory assessment and planning U.S. traditional and special 510(k) Pre-Market Approval (PMA) and de novo preparation and submission European technical file and design dossier preparation U.S. Investigational Device Exemption (IDE) preparation and submission Design control procedure implementation and completion of design history files Labeling and Instructions for Use (IFU) Clinical Evaluation Reports and Literature Reviews Medical Device Reporting and Vigilance Reporting Training and Mentoring FDA, Notified Body, and ISO 13485 registrar audit preparation and participation With 35+ years combined experience in medical devices, put our in depth of knowledge to work for you. Contact Information Christine Scifert, M.S., M.E.M. Phone: 901.831.8053 scifert@memphisregulatory.com Kim Strohkirch, M.S.E. Phone: 901.361.2037 strohkirch@memphisregulatory.com Dawn Norman, M.S. Phone: 618.604.3064 norman@memphisregulatory.com
