MRC|X offers a comprehensive solution for your regulatory, quality or clinical consulting needs with a focus on life sciences, including medical devices, biologics and tissues.  We are proud to offer tailored services to meet your project completion or strategic guidance objectives, regardless of company size or budget.  We offer access to strategic reimbursement services (coverage, coding and payment services).  We also offer access to compliance services, such as development of compliance programs and policies and procedures to foster adherence to the AdvaMed Code of Ethics as well as assistance with Sunshine Act reporting.  In addition, we provide an array of other support services depending on the needs of our clients.  We are based in Memphis, TN, centrally located for your convenience.

Expert Services

  • Global Regulatory assessment, planning and strategy
  • Traditional and special 510(k), Pre-Market Approval (PMA) and de novo preparation and submission
  • European technical file and design dossier preparation
  • FDA, Notified Body, and ISO 13485 registrar audit preparation and participation
  • Quality Systems
    • Establish 21 CFR 820 and ISO 13845 Quality System
    • Provide short-term or interim Quality System maintenance
    • Prepare and assist with Medical Device Single Audit Program (MDSAP)
  • Tissue Auditing, Licensing and Registration
  • Supplier and Internal Audits
  • Design Controls implementation and completion of Design History Files
  • Clinical Evaluation Reports and Literature Reviews
  • Medical Device Reporting and Vigilance Reporting
  • Labeling and Instructions for Use
  • Promotional literature assessments including surgical techniques, brochures and websites
  • Remediation resulting of audits or inspections
  • Training and Mentoring
  • Due Diligence and Integration Planning

Device Experience

  • Spinal, orthopedic, trauma and neurological implants and bone void fillers
  • Biologic, tissue and human cellular based products
  • Ophthalmic disease screening devices and instruments
  • Medical mobile applications
  • Capital equipment with software (cardiac, imaging, navigation, light and laser based devices)
  • Dental devices

Prior to consulting, Christine managed the regulatory group overseeing strategy and interfacing with governing bodies.  Dawn has managed regulatory, quality and clinical affairs departments at a variety of start-up companies.  With 40+ years combined experience in medical devices, we will put our depth of knowledge to work for you.

Compliance and Reimbursement Solutions

What’s your goal? High innovation/high growth in a new space? Establish industry leadership through alliances? Enhance existing products on the market or new sub-missions for medical devices, biologics and tissues? The Innovation Pipeline — idea, research, discovery, development – requires smart thinking. While you are focused on each phase, we are there to help you identify risks, comply, and ensure you can get reimbursed. MRC|X offers client-focused strategic planning designed to meet your goals. Our unique approach with a full suite of cutting-edge services that delivers results for your goals.

  • Reimbursement Support and Strategy Solutions
  • Coding, Coverage and Payment
  • Coordination with Patient and Physician Advocate Groups
  • HIPAA Privacy, Security and Breach Rule Services
  • Coordination with RDA Approval Entities
  • Serving as External Compliance Advisors
  • Mentoring and Coaching of Compliance Professionals
  • Compliance Risk Assessments, Program Effectiveness Evaluations and Training
  • Policy and Procedure Development
  • Mock Compliance Reviews
  • Federal Sunshine and State Reporting