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, Sunshine Act / Open Payments reporting, 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.

Device Experience

Spinal, orthopedic, trauma and neurological implants and bone void fillers
Biologic, tissue and human cellular based products
Medical mobile applications and clinical decision support software
Capital equipment with software (cardiac, infusion, imaging, navigation, robotics, light and laser- based devices)
Novel, breakthrough designation devices and applications
Dental, orthodontic and sleep based devices
Infusion and therapeutic based devices
Personal protection equipment (masks, gowns, drapes)
Wound dressings and antimicrobial coated devices

Our Locations

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