MCRA’s leading experts are specialized in achieving success with international regulatory bodies. Our team has industry leading experience with global regulatory strategy and deep understanding of the device lifecycle assisting through the developmental process, including conception and design considerations, pre-clinical and clinical testing, regulatory application through clearance/approval, and commercialization, providing MCRA's clients with the best representation to regulatory agencies in demonstrating the science, safety, and efficacy of their technologies.
Contact a Biologics Regulatory Expert
Biologics 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 hundreds of medical devices across the industry.
MCRA is a world-class provider of regulatory strategy and advice for biologics, combination and biologic related devices, including:
• Allografts and demineralized bone matrix products
• Autografts
• Bone cement
• Bone Morphogenic Proteins (BMP)
• Bone substitutes
• Cartilage repair systems
• Growth Factors
• Hyaluronic acid
• Orthobiologics
• Platelet concentration
• Resorbable fixation devices
• Scaffold devices
• Soft tissue and tendon grafts
• Stem cells
• Surgical glues
• Surgical sealants
• Synthetic cartilage
• Xenografts
International Regulatory Services
MCRA has industry leading specialization in the full spectrum of orthobiologics, and musculoskeletal related biologic and combination devices, with strong regulatory and scientific leadership offering deep expertise.
Our comprehensive regulatory services include:
• Global regulatory strategy
• Regulatory landscape assessment
• Gap analysis
• European Technical Files and Clinical Evaluation Reports (EU CER) compliant to the EU MDR
• Pre-clinical testing plan
• Clinical testing plan
• Due diligence services
• Agency/Notified Body interaction
• Device classification
• Import/export
• Labeling
• Device listing
• Establishment registration
• Regulatory file letters
• Medical device reporting