Contact an Orthopedic Regulatory Expert

Orthopedic Experience

MCRA’s team of experts has successfully navigated hundreds of international regulatory submissions. Our expertise extends to European, Australian, and Canadian markets, successfully remediating Technical Files and Clinical Evaluation Reports (EU CER) for compliance with MEDDEV 2.7.1. Rev. 4 for neurosurgical devices across the industry.

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

International Regulatory Services

MCRA has industry leading specialization in the full spectrum of musculoskeletal medical devices, supporting hundreds of clients seeking regulatory designations, clearances, and international registrations with proven track record of hundreds of Technical Files, Dossiers and CERs in oUS markets.

Our comprehensive regulatory services include: 

•    Agency/Notified Body interaction

•    Clinical testing plan

•    Design dossier and technical file gap assessment

•    Device classification

•    Device listing

•    Due diligence services

•    Establishment registration

•    European Technical Files and Clinical Evaluation Reports (EU CER) compliant to the EU MDR

•    Gap Assessment of Key Chemical/Material Restrictions (such as those found in REACH, RoHS, BPR & CLP)

•    Global regulatory strategy

•    Import/export

•    Labeling

•    Medical device reporting

•    Mock audits

•    Notified body submission/Response

•    Post-market surveillance 

•    Pre-clinical testing plan

•    Quality system gap assessment

•    Regulatory file letters

•    Regulatory landscape assessment

•    Training (EU MDR)

Contact an Orthopedic Regulatory Expert