Company Profile

MRC Global delivers comprehensive solutions for regulatory, quality, clinical, transactional and physician leadership/Key Opinion Leader (KOL) advisory services to the life sciences community – medical device, pharmaceutical, biologic and tissue companies.

Specific professional services include: global regulatory assessment, planning and strategy; pre-submission, 510(k), Investigational Device Exemption (IDE) Pre-Market Approval (PMA) and 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; and 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.

The varied life sciences experience includes spinal, orthopedic, trauma and neurological implants and bone void fillers; biologic, tissue and human cellular-based products; medical mobile applications; capital equipment with software (cardiac, infusion imaging, navigation, light and laser-based devices); personal protection equipment (masks, shields, gowns); and dental devices.