Contact an Orthopedic Regulatory Expert

Orthopedic Experience

MCRA’s team of experts has successfully navigated hundreds of US FDA submissions ranging from 510(k)s to PMAs involving advanced first-in-class orthopedic devices. 

MCRA is a world-class provider of regulatory strategy and advice for orthopedic and musculoskeletal devices, including: 

•    Allografts and demineralized bone matrix products 

•    Ambulation

•    Arthroscopy/Soft Tissue Repair

•    Autografts

•    Bone cement

•    Bone fixation and fracture repair devices

•    Bone Morphogenic Proteins (BMP)

•    Bone substitutes

•    Cartilage repair systems

•    Cartilage resurfacing devices and products

•    Growth Factors

•    Hyaluronic acid

•    Large and small joint replacement devices

•    Ligament repair

•    Limb lengthening

•    Long-bone defect repair

•    Orthotics and prosthetics

•    Osteomyelitis and peri-prosthetic infections

•    Osteoporosis

•    Pain relief

•    Platelet concentration

•    Resorbable fixation devices

•    Scaffold devices

•    Small bone implants

•    Soft tissue and tendon grafts

•    Spinal fusion (pedicle screw systems, vertebral body replacements, total disc replacements, cervical and lumbar cages, annulus repair devices, etc.)

•    Sports medicine

•    Stem cells

•    Surgical glues

•    Surgical sealants

•    Synthetic cartilage

•    Trauma

•    Xenografts

US Regulatory Services

MCRA has industry leading specialization in the full spectrum of musculoskeletal medical devices, supporting hundreds of clients seeking regulatory designations, clearances, and registrations with proven track record of nine approved musculoskeletal-device PMAs in the US.

Our comprehensive regulatory services include: 

•    Global and US regulatory strategy

•    Regulatory landscape assessment

•    Gap analysis

•    Investigational Device Exemption (IDE)

•    De Novo

•    510(k)

•    Premarket Approval (PMA)

•    FDA appeals

•    FDA training

•    FDA warning letters and 483 observations

•    Pre-clinical testing plan

•    Clinical testing plan

•    Due diligence services

•    Agency interaction

•    Device classification

•    Import/export

•    Labeling

•    FDA meeting strategy

•    Real-time reviews

•    Device listing

•    Establishment registration

•    Regulatory file letters

•    Medical device reporting

•    IDE Reporting

Contact an Orthopedic Regulatory Expert