We are leaders in designing and remediating quality management systems under strict and changing standards for orthopedic device companies. MCRA ensures compliance with ISO 13485, FDA Quality System Regulation, and other global QMS requirements, with special emphasis in establishing procedures for regulatory compliance tailored to your product line and target markets.
Contact an Orthopedic Quality Assurance Expert
Orthopedic Experience
MCRA offers unparalleled support to develop quality systems compliant with ISO 13485, FDA Quality System Regulation and other global QMS requirements to support development of orthopedic and musculoskeletal devices. Our interdisciplinary team will help you assure ongoing compliance with design control procedures for orthopedic and musculoskeletal devices all the way from device conception through release to market. Some key therapy areas of expertise include:
• 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
Quality Assurance Services
Our team offers setup of procedures for document control, R&D, risk management, software development, supplier evaluation, and control of measurement equipment, amongst others.
Our comprehensive quality assurance and manufacturing services include:
• Quality System Development
• Gap assessments
• Manufacturing and materials
• Mobile apps and software
• Mock inspections
• Perform internal quality system audits
• QA support
• Technical documentation and technical submissions