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.
Regulatory & Submission
MRC Global uses their consultant’s comprehensive knowledge of the regulatory submissions process to create and present submissions for approval and provide solutions for regulatory needs.
Quality Management Systems
MRC Global addresses Quality System needs to ensure compliance with applicable regulatory requirements, including Domestic and International Medical Devices Regulations.
Clinical Affairs & Compliance Services
MRC Global offers clinical consulting services to meet your clinical project goals.
Strategy, Operations & Marketing
No matter what stage a business is in (startup, commercialization or exit), we assist clients in strengthening core components that improve internal performance and elevate external market value.
Business Valuation & Co-Branding FMV
MRC Global performs comprehensive valuation analyses to support transactions.
- 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)
Through our alliance with Pinnacle, MRC Global has a significant national presence and serves clients in the United States, Europe and Asia.