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, 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.

Please contact our Partners who can assist you and your company

Dawn Norman, MS

Christine Scifert, MS, MEM

David V. White

Global Headquarters
MRC Global, LLC
9085 E. Mineral Circle, Suite 110
Centennial, CO 80112