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:
With 35+ years combined experience in medical devices, put our in depth of knowledge to work for you.
- 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
Dawn Norman, M.S.