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