Since 2004, MCRA’s US regulatory consulting team has led some of the most important projects in the neuro-musculoskeletal industry and has been at the forefront of many changing dynamics that positively affected the industry as a whole. Our cross-disciplinary approach, deep bench of talent in virtually every discipline, and knowledge of and contacts with U.S. government agencies enables us to help clients operate, expand, and achieve their long-term business objectives. MCRA’s regulatory team includes former FDA experts at the most senior levels, with engineering and scientific backgrounds that enable the team to have an in-depth understanding of orthopedic and spinal technologies and the related regulatory pathways. MCRA understands the entire process from invention to pre-clinical testing to commercialization, which allows MCRA’s clients to receive the best representation to regulatory agencies in demonstrating the science, safety, and efficiency of their technology(s). MCRA’s regulatory team is able to implement strategies from initial concept development through market launch, or can assist the client on one component of the project.
MCRA’s regulatory team consists of scientists, engineers, and biostatisticians. The team is led by former CDRH Branch Chief, Glenn Stiegman, who has 15 years of experience working in orthopedic regulation for the FDA and leading a team of scientists, clinicians, and engineers. Our regulatory team is responsible for many of the most recent clearances and regulatory approvals in all areas of neuro-musculoskeletal, including biologics, reconstruction/arthroplasty, spine, extremities, and sports medicine. Lastly, MCRA’s regulatory team has been formed and is currently fully integrated with the clinical (CRO), reimbursement, and quality departments of MCRA, which offer unmatched expertise in relation to the complex and ever changing regulatory environment for musculoskeletal technologies.
MCRA’s regulatory services include:
Strategic Regulatory Advisory Services
FDA Submissions & Other Regulatory Services
Marketing & Labeling Regulatory Compliance
Clinical Evaluation Report (CER) Development & Updates
To speak with a regulatory consultant please call 202.552.5800