Specific professional services include: global regulatory assessment, planning and strategy; pre-submission, 510(k), Investigational Device Exemption (IDE), Pre-Market Approval (PMA), de novo preparation and submission to FDA; European technical file and design dossier preparation; FDA, Notified Body, and ISO 13485 audit preparation and participation; Tissues auditing, licensing and registration; supplier and internal audits, valuation services (company or device), royalty arrangements, co-branding FMV and innovative processes to document KOL status and payment rate sheet development, to name a few.

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
  • Personal protection equipment (masks, shields, gowns)

Affiliated Companies

MRC Global’s affiliated companies provide us with additional resources and talent, further expanding our expertise, capacity and reach.
Click on the logos below to learn more about how these independent companies are changing healthcare as innovators in their field.

Drew Hoffman

MBA
Director

Our Locations

Through our alliance with Pinnacle, MRC Global has a significant national presence and serves clients in the United States, Europe and Asia.